FibromyalgiaPhase 2NCT00696787

A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

A Phase 2 study testing Desvenlafaxine Sustained Release (DVS SR) and Lyrica® (Pregabalin) in people with Fibromyalgia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fibromyalgia
What is being tested?: Desvenlafaxine Sustained Release (DVS SR) and Lyrica® (Pregabalin)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 27 sitesUnited States
Study dates: Jun 2008to Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Who cannot join

Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
Treatment with other drugs for fibromyalgia with 14 days of study start or during the study

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Study site
Austin, Texas, 78756
Study site
Chattanooga, Tennessee, 37404
Study site
Chattanooga, Tennessee, 37421
Study site
Cincinnati, Ohio, 45219
Study site
Dallas, Texas, 75231
Study site
Dayton, Ohio, 45408
Study site
Decatur, Georgia, 30033
Study site
Duncansville, Pennsylvania, 16635
Study site
Evansville, Indiana, 47714
Study site
Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46260
Study site
Jacksonville, Florida, 32216
Study site
Knoxville, Tennessee, 37920
Study site
Lansing, Michigan, 48910
Study site
Lexington, Kentucky, 40509
Study site
Middleton, Wisconsin, 53562
Study site
Philadelphia, Pennsylvania, 19152
Study site
Raleigh, North Carolina, 27612
Study site
Rockville, Maryland, 20852
Study site
Roseville, California, 95661
Study site
Salt Lake City, Utah, 84102
Study site
San Antonio, Texas, 78205
Study site
San Diego, California, 92108
Study site
San Diego, California, 92128
Study site
Santa Ana, California, 92705
Study site
Tampa, Florida, 33606
Study site
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome

The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.

Conditions: Fibromyalgia
Being tested: Desvenlafaxine Sustained Release (DVS SR), Lyrica® (Pregabalin), Placebo
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desvenlafaxine Sustained Release (DVS SR)Drug
Lyrica® (Pregabalin)Drug
PlaceboDrug

Study groups in NCT00696787
Study group	Role	What they receive
Placebo	Placebo comparator	In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. Receives: Drug: Placebo
DVS SR	Experimental	In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. Receives: Drug: Desvenlafaxine Sustained Release (DVS SR)
Pregabalin	Active comparator	In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor. Receives: Drug: Lyrica® (Pregabalin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline on the Numeric Rating Scale (NRS)
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Measured: Baseline and 8 weeks

Secondary outcomes (1)

Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jan 2009

First posted13 Jun 2008 (estimated)
Study startJun 2008
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00696787
Sponsor's protocol ID: 3151A4-2003
Status last verified: Feb 2013
First submitted: 11 Jun 2008
Last updated: 25 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
ClinicalTrials.gov ID: NCT00696787
Acronym / sponsor ID: 3151A4-2003
Conditions: Fibromyalgia
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 125 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 13 Jun 2008 (estimated)
Results: Posted 23 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboIn the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
DVS SR	Experimental	Drug: Desvenlafaxine Sustained Release (DVS SR)In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
Pregabalin	Active comparator	Drug: Lyrica® (Pregabalin)In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Key exclusion criteria (3 listed)

Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
Treatment with other drugs for fibromyalgia with 14 days of study start or during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Desvenlafaxine Sustained Release (DVS SR)	Drug	DVS SR
Lyrica® (Pregabalin)	Drug	Pregabalin
Placebo	Drug	Placebo

Primary outcome

Change From Baseline on the Numeric Rating Scale (NRS)
Time frame: Baseline and 8 weeks
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.

1 secondary outcome

Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
Time frame: Baseline and 8 weeks

Results and safety

Results posted to the registry on 23 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	25
DVS SR	42	22
Pregabalin	43	17

Primary outcome: Change From Baseline on the Numeric Rating Scale (NRS)

Time frame: Baseline and 8 weeks. Mean (Standard Error). Unit: units on scale

Measure	Placebo n = 40	DVS SR n = 42	Pregabalin n = 43
Value	-1.98 (0.37)	-1.60 (0.37)	-1.70 (0.38)

Placebo vs DVS SR: Adjusted mean: -0.38 (95% CI -1.42 to 0.66), p = 0.471, ANCOVA
Placebo vs Pregabalin: Adjusted mean: -0.28 (95% CI -1.33 to 0.77), p = 0.604, ANCOVA

Population analysed: The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 40 (0%)	25 of 40 (62.5%)	Not reported
DVS SR	0 of 42 (0%)	25 of 42 (59.5%)	Not reported
Pregabalin	1 of 43 (2.3%)	32 of 43 (74.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline on the Numeric Rating Scale (NRS) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00696787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.