Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women (REASSURE)

October 30, 2024 updated by: Iterum Therapeutics, International Limited

A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.

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

IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).

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.
2229

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 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Medical facility
      • Saraland, Alabama, United States, 36571
        • Medical facility
      • Sheffield, Alabama, United States, 35660
        • Medical facility
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Medical facility
      • Phoenix, Arizona, United States, 85032
        • Medical facility
      • Phoenix, Arizona, United States, 85031
        • Medical Facility3
      • Phoenix, Arizona, United States, 85051
        • Medical Facility2
      • Tucson, Arizona, United States, 85715
        • Medical facility
    • Arkansas
      • Hot Springs, Arkansas, United States, 71901
        • Medical Facility2
      • Hot Springs, Arkansas, United States, 71913
        • Medical facility
    • California
      • Bakersfield, California, United States, 93309
        • Medical facility
      • Chula Vista, California, United States, 91911
        • Medical facility
      • Fullerton, California, United States, 92835
        • Medical facility
      • Garden Grove, California, United States, 92844
        • Medical facility
      • Huntington Beach, California, United States, 92648
        • Medical facility
      • Huntington Park, California, United States, 90255
        • Medical Facility 2
      • Huntington Park, California, United States, 90255
        • Medical facility
      • Irvine, California, United States, 92614
        • Medical facility
      • La Mesa, California, United States, 91942
        • Medical facility
      • Lancaster, California, United States, 93534
        • Medical facility
      • Lomita, California, United States, 90717
        • Medical facility
      • Los Angeles, California, United States, 90057
        • Medical facility
      • Los Angeles, California, United States, 90017
        • Medical Facility2
      • Pomona, California, United States, 91768
        • Medical facility
      • Sacramento, California, United States, 95821
        • Medical facility
      • San Diego, California, United States, 92111
        • Medical facility
      • Upland, California, United States, 91786
        • Medical facility
      • Victorville, California, United States, 92395
        • Medical facility
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Medical facility
      • Lakewood, Colorado, United States, 80228
        • Medical facility
    • Florida
      • Aventura, Florida, United States, 33180
        • Medical facility
      • Boynton Beach, Florida, United States, 33435
        • Medical facility
      • Cape Coral, Florida, United States, 33909
        • Medical facility
      • Doral, Florida, United States, 33166
        • Medical facility
      • Edgewater, Florida, United States, 32132
        • Medical facility
      • Hialeah, Florida, United States, 33016
        • Medical facility
      • Hollywood, Florida, United States, 33024
        • Medical facility
      • Homestead, Florida, United States, 33032
        • Medical facility
      • Lake Worth, Florida, United States, 33460
        • Medical facility
      • Lake Worth, Florida, United States, 33461
        • Medical Facility2
      • Leesburg, Florida, United States, 34748
        • Medical facility
      • Miami, Florida, United States, 33165
        • Medical facility
      • Miami, Florida, United States, 33126
        • Medical Facility3
      • Miami, Florida, United States, 33135
        • Medical Facility2
      • Miami, Florida, United States, 33173
        • Medical Facility9
      • Miami, Florida, United States, 33175
        • Medical Facility5
      • Miami, Florida, United States, 33176
        • Medical Facility8
      • Miami, Florida, United States, 33179
        • Medical Facility6
      • Miami, Florida, United States, 33184
        • Medical Facility7
      • Miami, Florida, United States, 33186
        • Medical Facility4
      • Miami Beach, Florida, United States, 33140
        • Medical facility
      • Miami Gardens, Florida, United States, 33056
        • Medical facility
      • Miami Lakes, Florida, United States, 33016
        • Medical Facility2
      • Miami Lakes, Florida, United States, 33317
        • Medical facility
      • Orlando, Florida, United States, 32806
        • Medical facility
      • Orlando, Florida, United States, 32812
        • Medical Facility2
      • Ormond Beach, Florida, United States, 32174
        • Medical facility
      • Pompano Beach, Florida, United States, 33060
        • Medical facility
      • Sweetwater, Florida, United States, 33172
        • Medical facility
      • Tamarac, Florida, United States, 33321
        • Medical facility
      • Tampa, Florida, United States, 33603
        • Medical facility
      • Tampa, Florida, United States, 33607
        • Medical Facility3
      • Tampa, Florida, United States, 33607
        • Medical Facility4
      • Tampa, Florida, United States, 33614
        • Medical Facility2
      • Tampa, Florida, United States, 33634
        • Medical Facility5
      • Winter Haven, Florida, United States, 33880
        • Medical facility
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Medical facility
      • Atlanta, Georgia, United States, 30309
        • Medical Facility3
      • Atlanta, Georgia, United States, 30329
        • Medical Facility2
      • Decatur, Georgia, United States, 30034
        • Medical facility
      • Lawrenceville, Georgia, United States, 30046
        • Medical facility
      • Union City, Georgia, United States, 30291
        • Medical facility
      • Woodstock, Georgia, United States, 30189
        • Medical facility
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Medical facility
      • Idaho Falls, Idaho, United States, 83404
        • Medical facility
      • Idaho Falls, Idaho, United States, 08340
        • Medical Facility2
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Medical facility
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Medical facility
      • Mandeville, Louisiana, United States, 70471
        • Medical facility
      • Marrero, Louisiana, United States, 70072
        • Medical facility
      • Metairie, Louisiana, United States, 70001
        • Medical facility
      • New Orleans, Louisiana, United States, 70124
        • Medical facility
      • New Orleans, Louisiana, United States, 70127
        • Medical Facility2
      • Prairieville, Louisiana, United States, 70769
        • Medical facility
      • Shreveport, Louisiana, United States, 71106
        • Medical facility
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Medical facility
      • Oxon Hill, Maryland, United States, 20745
        • Medical facility
      • Towson, Maryland, United States, 21204
        • Medical facility
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Medical facility
      • Gulfport, Mississippi, United States, 39503
        • Medical facility
      • Jackson, Mississippi, United States, 39202
        • Medical facility
      • Ridgeland, Mississippi, United States, 39157
        • Medical facility
    • Montana
      • Great Falls, Montana, United States, 59405
        • Medical facility
      • Kalispell, Montana, United States, 59901
        • Medical facility
      • Missoula, Montana, United States, 59804
        • Medical facility
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Medical facility
      • Las Vegas, Nevada, United States, 89113
        • Medical Facility2
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Medical Facility2
      • Albuquerque, New Mexico, United States, 87109
        • Medical facility
    • New York
      • Bronx, New York, United States, 10456
        • Medical facility
      • Brooklyn, New York, United States, 11215
        • Medical facility
      • Brooklyn, New York, United States, 11229
        • Medical Facility2
      • Garden City, New York, United States, 11530
        • Medical facility
      • Schenectady, New York, United States, 12304
        • Medical facility
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Medical facility
      • Greensboro, North Carolina, United States, 27405
        • Medical facility
      • New Bern, North Carolina, United States, 28562
        • Medical facility
      • Winston-Salem, North Carolina, United States, 27103
        • Medical facility
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Medical facility
      • Columbus, Ohio, United States, 43213
        • Medical Facility2
      • Columbus, Ohio, United States, 43228
        • Medical facility
      • Dayton, Ohio, United States, 45409
        • Medical facility
      • Dayton, Ohio, United States, 45424
        • Medical Facility2
      • Lima, Ohio, United States, 45805
        • Medical facility
      • Middleburg Heights, Ohio, United States, 44130
        • Medical facility
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Medical facility
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Medical facility
      • Portland, Oregon, United States, 97202
        • Medical facility
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Medical facility
      • Scottdale, Pennsylvania, United States, 15683
        • Medical facility
      • Smithfield, Pennsylvania, United States, 15478
        • Medical facility
      • Upper Saint Clair, Pennsylvania, United States, 15241
        • Medical facility
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Medical facility
      • Easley, South Carolina, United States, 29640
        • Medical facility
      • Greenville, South Carolina, United States, 29607
        • Medical facility
      • Lancaster, South Carolina, United States, 29720
        • Medical facility
      • Myrtle Beach, South Carolina, United States, 29572
        • Medical facility
      • Powdersville, South Carolina, United States, 29611
        • Medical facility
      • Seneca, South Carolina, United States, 29678
        • Medical facility
      • Summerville, South Carolina, United States, 29485
        • Medical facility
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Medical Facility2
      • Chattanooga, Tennessee, United States, 37421
        • Medical facility
      • Hendersonville, Tennessee, United States, 37075
        • Medical facility
      • Memphis, Tennessee, United States, 38120
        • Medical facility
      • Nashville, Tennessee, United States, 37209
        • Medical facility
    • Texas
      • Austin, Texas, United States, 78723
        • Medical facility
      • Carrollton, Texas, United States, 75007
        • Medical facility
      • Carrollton, Texas, United States, 75010
        • Medical Facility2
      • Corpus Christi, Texas, United States, 78404
        • Medical facility
      • Dallas, Texas, United States, 75209
        • Medical facility
      • Frisco, Texas, United States, 75033
        • Medical facility
      • Georgetown, Texas, United States, 79628
        • Medical facility
      • Houston, Texas, United States, 77036
        • Medical Facility2
      • Houston, Texas, United States, 77074
        • Medical facility
      • Kingwood, Texas, United States, 77339
        • Medical facility
      • League City, Texas, United States, 77573
        • Medical facility
      • McKinney, Texas, United States, 75069
        • Medical Facility2
      • McKinney, Texas, United States, 75070
        • Medical facility
      • Mesquite, Texas, United States, 75149
        • Medical Facility2
      • Mesquite, Texas, United States, 75149
        • Medical facility
      • Missouri City, Texas, United States, 77459
        • Medical facility
      • Pearland, Texas, United States, 77584
        • Medical facility
      • Plano, Texas, United States, 75024
        • Medical Facility2
      • Plano, Texas, United States, 75093
        • Medical facility
      • San Antonio, Texas, United States, 78215
        • Medical facility
      • Sugar Land, Texas, United States, 77479
        • Medical Facility 2
      • Sugar Land, Texas, United States, 77479
        • Medical Facility3
      • Sugar Land, Texas, United States, 77479
        • Medical facility
    • Utah
      • Draper, Utah, United States, 84020
        • Medical Facility 2
      • Draper, Utah, United States, 84020
        • Medical facility
      • Pleasant Grove, Utah, United States, 84062
        • Medical facility
      • Salt Lake City, Utah, United States, 84107
        • Medical facility
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Medical facility
      • Manassas, Virginia, United States, 20110
        • Medical facility
      • Norfolk, Virginia, United States, 23502
        • Medical facility
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Medical facility
      • Morgantown, West Virginia, United States, 26505
        • Medical facility

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

Description

Inclusion Criteria:

  • Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
  • Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
  • A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine

Exclusion Criteria:

  • Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
  • Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
  • Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
  • Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
  • Ongoing urinary retention
  • Neurogenic bladder
  • Current resident of a long-term care facility
  • Instrumentation of urinary tract in the previous 30 days
  • An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
  • Any history of trauma to the pelvis or urinary tract
  • Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
  • History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients

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.
Experimental: Sulopenem etzadroxil/probenecid
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Drug: Sulopenem etzadroxil/probenecid
Oral sulopenem twice daily for 5 days
Other Names:
  • Oral sulopenem
Active Comparator: Amoxicillin/clavulanate
Amoxicillin/clavulanate PO twice daily for 5 days
Drug: Amoxicillin/clavulanate
Oral Augmentin twice daily for 5 days
Other Names:
  • Augmentin

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
Overall Success
Time Frame: Day 12+/-1 day
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Day 12+/-1 day
Overall Success Susceptible Population
Time Frame: Day 12+/-1 day
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Day 12+/-1 day

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
Clinical Success Modified Intent-to-treat Population
Time Frame: Day 12+/-1 day
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Clinical Success
Time Frame: Day 12+/-1 day
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Clinical Success Susceptible Population
Time Frame: Day 12+/-1 day
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Microbiologic Success
Time Frame: Day 12+/-1 day
Eradication of the Baseline Pathogen
Day 12+/-1 day
Microbiologic Success Susceptible Population
Time Frame: Day 12+/-1 day
Microbiologic Success: Eradication of the Baseline Pathogen
Day 12+/-1 day

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.
Iterum Therapeutics, International Limited

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.
  • Study Director: Sailaja Puttagunta, MD, Iterum Therapeutics

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 (Actual)

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.
October 18, 2022

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.
November 3, 2023

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.
November 21, 2023

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).
October 14, 2022

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.
October 14, 2022

First Posted (Actual)

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.
October 18, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
November 20, 2024

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.
October 30, 2024

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.
October 1, 2024

More Information

Terms related to this study

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.
  • IT001-310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings