Back to resultsA Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
AD 337
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring ACR 1990 Fibromyalgia, Fibromyalgia Impact Questionnaire
Eligibility Criteria
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.
Sites / Locations
- David L Scott
Outcomes
Primary Outcome Measures
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00377039
Brief Title
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sosei
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
ACR 1990 Fibromyalgia, Fibromyalgia Impact Questionnaire
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AD 337
Primary Outcome Measure Information:
Title
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
Secondary Outcome Measure Information:
Title
These will be
Title
FIQ Total score at weeks 1, 2, 3, at end of study and overall
Title
FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall
Title
Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall
Title
Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall
Title
Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall
Title
Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Scott
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
David L Scott
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
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