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

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

September 14, 2006
September 15, 2006
October 2, 2007
August 2006
Not Provided
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
Same as current
Complete list of historical versions of study NCT00377039 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Fibromyalgia
Drug: AD 337
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
August 2007
Not Provided

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.
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00377039
AD337-021
Not Provided
Not Provided
Not Provided
Not Provided
Sosei
Not Provided
Principal Investigator: David L Scott King's College London
Sosei
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP