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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:
ClinicalTrials.gov Identifier:
NCT00377039
First Posted: September 15, 2006
Last Update Posted: October 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sosei
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00377039     History of Changes
Other Study ID Numbers: AD337-021
First Submitted: September 14, 2006
First Posted: September 15, 2006
Last Update Posted: October 2, 2007
Last Verified: September 2007

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