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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014