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

This study has been completed.
Sponsor:
Information provided by:
Sosei
ClinicalTrials.gov Identifier:
NCT00377039
First received: September 14, 2006
Last updated: September 30, 2007
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
 Drug: AD 337
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Sosei:

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

Estimated Enrollment: 100
Study Start Date: August 2006
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377039

Locations
United Kingdom
David L Scott
London, United Kingdom
Sponsors and Collaborators
Sosei
Investigators
Principal Investigator: David L Scott King's College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00377039     History of Changes
Other Study ID Numbers: AD337-021
Study First Received: September 14, 2006
Last Updated: September 30, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sosei:
ACR 1990 Fibromyalgia
Fibromyalgia Impact Questionnaire

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013