Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.

January 28, 2015 updated by: BioCryst Pharmaceuticals

A Phase II, Multicenter, Randomized, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.

This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study. A series of Phase 1 studies in human volunteers was completed that provided safety and pharmacokinetic results that supported the initiation of this Phase 2 multinational, randomized, double-mask study that compared the antiviral efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. Because of the unique pharmacokinetic and pharmacodynamic properties of peramivir - a long terminal half life in plasma and an extended duration of binding to the neuraminidase enzyme - subjects were randomized in a 1:1:1 ratio to receive a single dose of one of three treatments: peramivir 150 mg, peramivir 300 mg, and placebo. Study drug was administered as one 2-mL intramuscular injection in each gluteal muscle (total of 4 mL, injected in divided doses). This multinational study was originally to be conducted at approximately 80 sites in the US and Canada. When enrollment during the North American influenza season of 2006-2007 did not achieve the target, the study was extended to sites in Australia, New Zealand, South Africa, and Hong Kong.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
344

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3C3P1
        • Calgary West Medical Cnetre Clinical Studies
      • Edmonton, Alberta, Canada, T5COA3
        • Belvedere Medicentre
      • Edmonton, Alberta, Canada, T5COA3
        • Hermitage Medicentres
      • Edmonton, Alberta, Canada, T5N2N8
        • RJA Medicentres
      • Edmonton, Alberta, Canada, T5X3N5
        • Castledowns Medicentre
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Gain Medical Centre
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A1A1
        • Source Unique Clinic
      • Toronto, Ontario, Canada, M9W4L6
        • Manna Research
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Omnispec Clinical Reasearch Inc
      • Ste-Foy, Quebec, Canada, G1V4P9
        • Clinique Médicale des Campus
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 5M3
        • Prairie Clinical
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Radiant Research
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Clopton Clinic
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • Carmichael, California, United States, 95608
        • Medical Center
      • El Centro, California, United States, 92243
        • Pacific Sleep Medicines Service
      • Orange, California, United States, 92869
        • Advanced Clinical Research Institute
      • Sacramento, California, United States, 95816
        • Benchmark Research
      • San Diego, California, United States, 92121
        • Pacific Sleep Medicine Services
      • San Francisco, California, United States, 94105
        • Pacific Sleep Medicine Services
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Alpine Clinical Research Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Unviersity
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of Southern Florida
      • DeLand, Florida, United States, 32720
        • University Clinical Research-Deland, LLC
      • Gainesville, Florida, United States, 32607
        • Florida Medical Research Institute
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32205
        • Jacksonville Center for Clinical Research
      • Sarasota, Florida, United States, 34239
        • Clinical Research Center
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Georgia Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Hospital
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Radiant Research
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric / Adult Research
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Assoc, Inc
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Benchmark Research
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research, Minneapolis
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital Emergency Department
      • St. Louis, Missouri, United States, 63124
        • Medex Healthcare Research, Inc.
      • St. Louis, Missouri, United States, 63141
        • Radiant Research
    • Montana
      • Bozeman, Montana, United States, 59715
        • Bozeman Urgent Care Center
    • Nebraska
      • Alliance, Nebraska, United States, 69301
        • Alliance Medical Center
      • Omaha, Nebraska, United States, 68154
        • Midwest Family Physicians
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • UMDNJ
      • East Brunswick, New Jersey, United States, 08816
        • Pulmonary & Critical Care Associates
    • New York
      • Brooklyn, New York, United States, 11201
        • Brooklyn Hospital Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group, Ltd.
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Integrated Medical Research, PC
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Research Across America at Oyster Point Family Health Center
      • Philadelphia, Pennsylvania, United States, 19115
        • Radiant Research
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physicians Research, Inc
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research, Inc
      • Cranston, Rhode Island, United States, 02920
        • Paragon Clinical Research, Inc.
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Family Practice
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Dallas, Texas, United States, 75235
        • Radiant Research
      • Garland, Texas, United States, 75041
        • Towngate Plaza Medical Center
      • Houston, Texas, United States, 77030
        • Baylor Clinic-Baylor College of Medicine
      • San Antonio, Texas, United States, 78213
        • Gsa Research
      • San Antonio, Texas, United States, 78217
        • Radiant Research-San Antonio Northeast
      • San Antonio, Texas, United States, 78229
        • Radiant Research San Antonio
      • Tomball, Texas, United States, 77375
        • Balbir Chahal M.D. ,P.A
      • Tomball, Texas, United States, 77375
        • Dynamed Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. Foothill Family Clinic South
      • West Jordan, Utah, United States, 84084
        • J. Lewis Research, Inc./Southwest Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. However, this requirement is waived if the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening.
  • Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
  • Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)
  • Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
  • Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.

  • Females of childbearing potential must report one of the following:

    • Be surgically sterile
    • Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study drug administration
    • Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study drug administration
    • Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.

Exclusion Criteria:

  • Women who are breast-feeding
  • History of diagnosed chronic obstructive pulmonary disease or diagnosis of severe persistent asthma
  • History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)
  • History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months
  • Immunocompromised status due to illness or previous organ transplant
  • Current use of systemic immunosuppressive medications (except inhaled corticosteroids)
  • Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days
  • Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
  • Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics
  • Clinically significant signs of acute respiratory distress
  • Clinically significant signs of acute cardiac disease
  • Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia
  • Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es)
  • History of hepatitis B, hepatitis C, or human immunodeficiency virus infection
  • History of alcohol abuse or drug addiction within 1 year prior to admission in the study
  • Participation in a study of any investigational drug within the last 30 days
  • Positive urine pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Experimental: Peramivir 150 mg
Drug: Peramivir 150 mg
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Other Names:
  • BCX1812
Experimental: Peramivir 300 mg
Drug: Peramivir 300 mg
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Other Names:
  • BCX1812

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Time Frame: Up to 14 days
Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.
Up to 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Resolution of Fever
Time Frame: Up to 14 days
The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.
Up to 14 days
Time to Resumption of Ability to Perform Usual Activities
Time Frame: Up to 14 days
The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.
Up to 14 days
Change From Baseline to Day 2 in Influenza Virus Titer
Time Frame: Baseline and approximately 24 hours after treatment
The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Baseline and approximately 24 hours after treatment
Change From Baseline to Day 3 in Influenza Virus Titer
Time Frame: Baseline and approximately 48 hours after treatment
The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Baseline and approximately 48 hours after treatment
Change From Baseline to Day 5 in Influenza Virus Titer
Time Frame: Baseline and approximately 96 hours after treatment
The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Baseline and approximately 96 hours after treatment
Change From Baseline to Day 9 in Influenza Virus Titer
Time Frame: Baseline and approximately 192 hours after treatment
The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).
Baseline and approximately 192 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioCryst Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wayne Harper, MD, Wake Research Associates, LLC
  • Principal Investigator: Monica Pierson, MD, Radiant Research
  • Principal Investigator: Stanley Block, MD, Kentucky Pediatric/Adult Research
  • Principal Investigator: James Borders, MD, Central Kentucky Research Assoc, Inc
  • Principal Investigator: Robert Broker, MD, Hillcrest Family Practice
  • Principal Investigator: Paul Browstone, MD, Alpine Clinical Research Center
  • Principal Investigator: Jeffry Jacqmein, MD, Jacksonville Center for Clinical Research
  • Principal Investigator: Isaac Marcadis, MD, Palm Beach Research Center
  • Principal Investigator: Mark Stich, MD, Jacksonville Center for Clinical Research
  • Principal Investigator: George Atiee, MD, Gsa Research
  • Principal Investigator: Joe Blumenau, MD, Research Across America
  • Principal Investigator: John Champlin, MD, Medical Center
  • Principal Investigator: Shane Christensen, MD, J. Lewis Research, Inc. Foothill Family Clinic South
  • Principal Investigator: Steven Duckor, MD, Advanced Clinical Research Institute
  • Principal Investigator: Lewis Eirinberg, MD, Midwest Family Physicians
  • Principal Investigator: Milton K. Erman, MD, Pacific Sleep Medicine Services
  • Principal Investigator: Stanley Cohen, MD, Radiant Research
  • Principal Investigator: David L. Fried, MD, Omega Medical Research
  • Principal Investigator: Yury Furman, MD, Pacific Sleep Medicine Services, Inc.
  • Principal Investigator: Dan C Henry, MD, J. Lewis Research, Inc. Foothill Family Clinic
  • Principal Investigator: John M. Hill, MD, University Clinical Research-Deland, LLC
  • Principal Investigator: Veryl Hodges, DO, Clopton Clinic
  • Principal Investigator: Reuben Holland, III, MD, Clinical Research Center
  • Principal Investigator: William Jennings, MD, Radiant Research San Antonio
  • Principal Investigator: James Edmond Kelaher, MD,MPH, Baylor Clinic-Baylor College of Medicine
  • Principal Investigator: Allan Kelly, MD, Hermitage Medicentres
  • Principal Investigator: Ben Lasko, MD, Manna Research
  • Principal Investigator: Mark Leber, MD, The Brooklyn Hospital Center
  • Principal Investigator: Larissa Lim, MD, Florida Medical Research Institute
  • Principal Investigator: Alain Martel, MD, Clinique Médicale des Campus
  • Principal Investigator: Dennis Mikolich, MD, Paragon Clinical Research, Inc.
  • Principal Investigator: Julie Mullen, MD, Sterling Research Group, Ltd.
  • Principal Investigator: David Parenti, MD, George Washington University
  • Principal Investigator: Robert Poirier, MD, Barnes-Jewish Hospital Emergency Department
  • Principal Investigator: Ivan Rarick, MD, Benchmark Research
  • Principal Investigator: Dennis Riff, MD, Advanced Clinical Research Institute
  • Principal Investigator: Q Rizvi, MD, Castledowns Medicentre
  • Principal Investigator: Michael Rokeach, MD, Pacific Sleep Medicine Services
  • Principal Investigator: Rawle Seupaul, MD, Wishard Hospital
  • Principal Investigator: Daniel Shu, MD, Gain Medical Research Centre
  • Principal Investigator: Steve Sitar, MD, Orange County Clinical Trials
  • Principal Investigator: Kirk Stiffler, MD, Summa Emergency Associates Inc.
  • Principal Investigator: Guy Tellier, MD, Omnispec clinical research inc
  • Principal Investigator: Michael Warren, MD, Research Across America at Oyster Point Family Health Center
  • Principal Investigator: Randall Watson, MD, J. Lewis Research, Inc./Southwest Family Medicine
  • Principal Investigator: John Michael Wise, MD, Bozeman Urgent Care Center
  • Principal Investigator: Chivers Woodruff, Jr., MD, Radiant Research
  • Principal Investigator: Bruce Berwald, MD, Radiant Research
  • Principal Investigator: Frank Maggiacomo, DO, New England Center for Clinical Research, Inc
  • Principal Investigator: Barry Packman, MD, Radiant Research
  • Principal Investigator: Sheila Rodstein, MD, Radiant Research, Minneapolis
  • Principal Investigator: Bernardo Ng, MD, Pacific Sleep Medicines Service
  • Principal Investigator: Gerardo Losoya, MD, Towngate Plaza Medical Center
  • Principal Investigator: Francis X. Burch, MD, Radiant Research-San Antonio Northeast
  • Principal Investigator: John P. Delgado, MD, Integrated Medical Research, PC
  • Principal Investigator: Edward Fein, MD, Pulmonary & Critical Care Associates
  • Principal Investigator: Bruce D. Forney, MD, Alliance Medical Center
  • Principal Investigator: James E. Greenwald, MD, Medex Healthcare Research, Inc.
  • Principal Investigator: Robert Hudrick, DO, University Of Medicine & Dentistry Of New Jersey
  • Principal Investigator: Robert Jeanfreau, MD, Benchmark Research
  • Principal Investigator: Robert Kaufmann, MD, Georgia Clinical Research
  • Principal Investigator: Sy Lam, MD, Calgary West Medical Centre Clinical Studies
  • Principal Investigator: Keith S. Reisinger, MD, MPH, Primary Physicians Research, Inc
  • Principal Investigator: Keith S. Reisinger, MD, MPH, Family Practice Medical Associates South
  • Principal Investigator: Earl Martin, MD, Dynamed Clinical Research
  • Principal Investigator: Jean-Sebastien Gauthier, MD, Q & T Research Inc.
  • Principal Investigator: Jeffrey Rosen, MD, Clinical Research of Southern Florida
  • Principal Investigator: Gerald Burns, MD, New Orleans Medical
  • Principal Investigator: Stewart Behiel, MD, Belvedere Medicentre
  • Principal Investigator: Giuseppe D'Ignazio, MD, Source Unique Clinic
  • Principal Investigator: Indravadan Dattani, MD, Prairie Clinical
  • Principal Investigator: Roy A. Gritter, MD, RJA Medicentres
  • Principal Investigator: Balbir Chahal, MD, Balbir Chahal M.D. ,P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCX1812-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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