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Completed

NCT Number: NCT00377039

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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

David L Scott

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AD 337

Drug

Primary outcomes

  1. The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary outcomes

  1. These will be

  2. FIQ Total score at weeks 1, 2, 3, at end of study and overall

  3. FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall

  4. Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall

  5. Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall

  6. Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall

  7. Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall

Sponsors and collaborators

Lead sponsor

Sosei

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Study completion
2007
First posted
Sep 15, 2006
Registry last updated
Oct 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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