Fibromyalgia Clinical Trial
Official title:
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.
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Female - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | David L Scott | London |
Lead Sponsor | Collaborator |
---|---|
Sosei |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment | |||
Secondary | These will be | |||
Secondary | FIQ Total score at weeks 1, 2, 3, at end of study and overall | |||
Secondary | FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall | |||
Secondary | Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall | |||
Secondary | Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall | |||
Secondary | Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall | |||
Secondary | Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall |
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