Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00357825
NCT00357825
Completed
Phase 2

An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia

Pfizer1 site in 1 country246 target enrollmentAugust 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPain
Drugs[S,S]-Reboxetine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pain
Sponsor
Pfizer
Enrollment
246
Locations
1
Primary Endpoint
Weekly Average Pain Score from the Daily Pain Diary.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
March 2007
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
  • •At screening and randomization, patients must have a score of \>/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).

Exclusion Criteria

  • •Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
  • •Patients with severe hepatic impairment.

Outcomes

Primary Outcomes

Weekly Average Pain Score from the Daily Pain Diary.

Secondary Outcomes

  • Fibromyalgia Impact Questionnaire (FIQ) Total Score
  • Patient Global Impression of Change
  • Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
  • Short-Form McGill Pain Questionnaire (SF-MPQ)
  • Exposure Response Relationship Between Daily Dose and Daily Pain Score
  • Short-Form 36 Health Survey (SF 36)
  • Sheehan Disability Scale
  • Quality of Sleep Score from the Daily Sleep Diary
  • Multidimensional Assessment of Fatigue (MAF)
  • Hospital Anxiety and Depression Scales (HADS)
  • Safety and Tolerability
  • Fibromyalgia Health Assessment Questionnaire (F-HAQ)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 2
Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment FailuresPain
NCT00143442Pfizer184
Completed
Phase 3
A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.Fibromyalgia
NCT00612170Pfizer1,129
Terminated
Phase 2
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.Diabetic Neuropathies
NCT00625833Pfizer330
Terminated
Phase 2
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.Pain
NCT00348894Pfizer136
Completed
Phase 2
[S,S]-Reboxetine Dose-Range Finding TrialPain
NCT00288652Pfizer280