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

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ClinicalTrials.gov Identifier: NCT00377039
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : October 2, 2007
Sponsor:
Information provided by:
Sosei

Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: AD 337 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.
Study Start Date : August 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia




Primary Outcome Measures :
  1. The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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

ClinicalTrials.gov Identifier: NCT00377039     History of Changes
Other Study ID Numbers: AD337-021
First Posted: September 15, 2006    Key Record Dates
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