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Clinical Trials/NCT00377039
NCT00377039
Completed
Phase 2

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Investigate the Efficacy, Safety and Tolerability of AD 337 in the Treatment of Fibromyalgia in Female Subjects.

Sosei1 site in 1 country100 target enrollmentAugust 2006
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ConditionsFibromyalgia
DrugsAD 337

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Sosei
Enrollment
100
Locations
1
Primary Endpoint
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.

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

Investigators

Sponsor
Sosei

Eligibility Criteria

Inclusion Criteria

  • •Age 18-65
  • •Meet ACR 1990 criteria for classification of Fibromyalgia
  • •Able and willing to discontinue CNS active therapies

Exclusion Criteria

  • •If pain is NOT primarily due to Fibromyalgia
  • •Current or prior history of serious psychiatric disorder
  • •Pregnant/breastfeeding
  • •QTc \> 470ms
  • •Failure to respond to 2 or more adequate regimes of different classes of antidepressants.

Outcomes

Primary Outcomes

The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary Outcomes

  • These will be
  • FIQ Total score at weeks 1, 2, 3, at end of study and overall
  • FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall
  • Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall
  • Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall
  • Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall
  • Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall

Study Sites (1)

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