A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377039
• Other study ID #: AD337-021
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2006
• Last updated: September 30, 2007
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: September 2007
• Source: Sosei
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2007
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• AD 337

Locations

Country	Name	City	State
United Kingdom	David L Scott	London

Sponsors (1)

Lead Sponsor	Collaborator
Sosei

Country where clinical trial is conducted

United Kingdom, 

Outcome

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