Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

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.

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.
137

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

  • Austria
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
      • Vienna, Austria, A-1080
        • Pfizer Investigational Site
  • Germany
      • Bad Saarow, Germany, 15526
        • Pfizer Investigational Site
      • Berlin, Germany, 10969
        • Pfizer Investigational Site
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
      • Mittweida, Germany, 09648
        • Pfizer Investigational Site
      • Muenchen, Germany, 80331
        • Pfizer Investigational Site
      • Oldenburg, Germany, 26122
        • Pfizer Investigational Site
      • Schwerin, Germany, 19053
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28036
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35406
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • San Diego, California, United States, 92121
        • Pfizer Investigational Site
      • Santa Monica, California, United States, 90404
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Pfizer Investigational Site
    • Georgia
      • Macon, Georgia, United States, 31201
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pfizer Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Pfizer Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Pfizer Investigational Site

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe idiopathic RLS
  • symptoms occur predominantly in the evening
  • symptoms interfere with sleep onset or maintenance

Exclusion Criteria:

  • Any secondary RLS
  • require treatment for daytime RLS symptoms
  • symptomatic neuropathies

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
  • Masking: DOUBLE

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: 1
Placebo
Drug: placebo
Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
Other Names:
  • Sugar pill
EXPERIMENTAL: 2
investigational treatment
Drug: Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
EXPERIMENTAL: 3
investigational treatment
Drug: Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
EXPERIMENTAL: 4
investigational treatment
Drug: Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
EXPERIMENTAL: 5
investigational treatment
Drug: Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
EXPERIMENTAL: 6
investigational treatment
Drug: Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008
Drug: Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
  • Lyrica, PD 0144723; CI-1008

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
Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
Time Frame: Baseline, Week 6
IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.
Baseline, Week 6

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
Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
Time Frame: Week 6
Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.
Week 6
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)
CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
Time Frame: Baseline,, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.
Baseline,, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline
Time Frame: Baseline,, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.
Baseline,, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.
Baseline, Week 1, Week 2, Week 4, Week 6
Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
Time Frame: Week 1, Week 2, Week 4, Week 6
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.
Week 1, Week 2, Week 4, Week 6
Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6
Time Frame: Baseline, Week 6
RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.
Baseline, Week 6
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Time Frame: Baseline, Week 6
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.
Baseline, Week 6
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Time Frame: Baseline, Week 6
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from "much worse now" to much better now." Recall period: month prior to the assessment.
Baseline, Week 6

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.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
April 1, 2008

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.
January 1, 2009

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.
January 1, 2009

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).
May 8, 2008

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.
May 12, 2008

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.
May 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

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 10, 2021

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 21, 2021

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.
June 1, 2010

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.
  • A0081183

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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