The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

October 24, 2011 updated by: Pfizer

The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study

Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

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.
500

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

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

        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4X7
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
        • Pfizer Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • Pfizer Investigational Site
      • Surrey, British Columbia, Canada, V4A 2H9
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Canada, R3T 2E8
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 2C2
        • Pfizer Investigational Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4S 1Y2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5C 1R6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 1N8
        • Pfizer Investigational Site
      • Pointe Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
      • Shawinigan, Quebec, Canada, G9N 2H6
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 4J6
        • Pfizer Investigational Site
      • St-Romuald, Quebec, Canada, G6W 5M6
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85710
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • Pfizer Investigational Site
      • Encinitas, California, United States, 92024
        • Pfizer Investigational Site
      • Foothill Ranch, California, United States, 92610
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
      • Longmont, Colorado, United States, 80501
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • Crystal River, Florida, United States, 34429
        • Pfizer Investigational Site
      • Deland, Florida, United States, 32720
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32606
        • Pfizer Investigational Site
      • Lake Worth, Florida, United States, 33461
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33169
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Pfizer Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Pfizer Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70002
        • Pfizer Investigational Site
    • Michigan
      • Canton, Michigan, United States, 48187
        • Pfizer Investigational Site
      • Ypsilanti, Michigan, United States, 48197
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131-2197
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03755
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87131
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103-4005
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Pfizer Investigational Site
      • Fargo, North Dakota, United States, 58104
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Pfizer Investigational Site
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Pfizer Investigational Site
    • Texas
      • Carrollton, Texas, United States, 75006
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Hurst, Texas, United States, 76054
        • Pfizer Investigational Site
      • Midland, Texas, United States, 79705
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
  • Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.

Exclusion Criteria:

  • History of a seizure disorder other than a single childhood febrile seizure.
  • History or presence of clinically important hepatic or renal disease or other medical disease.
  • Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.

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: Triple

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.
Active Comparator: A
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD
Active Comparator: B
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD
Active Comparator: C
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD
Active Comparator: D
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD
Active Comparator: E
Drug: Placebo
Tapering placebo
Active Comparator: F
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD
Active Comparator: G
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD
Placebo Comparator: H
Drug: desvenlafaxine succinate sustained release
Titration 100 mg
Drug: desvenlafaxine succinate sustained release
Titration 50 mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
Drug: desvenlafaxine succinate sustained release
Titration 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
Drug: desvenlafaxine succinate sustained release
Tapering 50 mg QOD

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
Number of Participants With Nausea During the First 2 Weeks of Treatment
Time Frame: Baseline up to Week 2
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
Baseline up to Week 2
Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
Time Frame: Week 17
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Week 17
DESS Total Score at End of Second Week of Tapering
Time Frame: Week 18
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Week 18
DESS Total Score at 1 Week After the End of Tapering
Time Frame: Week 19
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Week 19

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 Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Time Frame: Baseline up to Week 2
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Baseline up to Week 2
Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Time Frame: Baseline up to Week 2
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Baseline up to Week 2
Number of Participants With Each DESS at the End of First Week of Tapering
Time Frame: Week 17
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Week 17
Number of Participants With Each DESS at the End of Second Week of Tapering
Time Frame: Week 18
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Week 18
Number of Participants With Each DESS One Week After End of Tapering
Time Frame: Week 19
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Week 19
Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
Time Frame: Week 1 and Week 2
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Week 1 and Week 2
Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
Time Frame: Week 19
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Week 19
Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
Time Frame: Week 16
MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).
Week 16
Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12 and Week 16
MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.
Baseline, Week 4, Week 8, Week 12 and Week 16

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Age of the Participants in Tapering Phase
Time Frame: Week 17
Participants were re-randomized to tapering phase after OL phase.
Week 17
Gender of the Participants in Tapering Phase
Time Frame: Week 17
Participants were re-randomized to tapering phase after OL phase.
Week 17

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

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.

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.
December 1, 2006

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, 2008

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, 2008

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).
November 17, 2006

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.
November 17, 2006

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.
November 20, 2006

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.
October 26, 2011

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 24, 2011

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, 2011

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.
  • 3151A2-405

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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