NCT00377039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 2, 2007

Status Verified

September 1, 2007

First QC Date

September 14, 2006

Last Update Submit

September 30, 2007

Conditions

Fibromyalgia

Keywords

ACR 1990 FibromyalgiaFibromyalgia Impact Questionnaire

Outcome Measures

Primary Outcomes (1)

  • The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

AD 337DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age 18-65
  • Meet ACR 1990 criteria for classification of Fibromyalgia
  • Able and willing to discontinue CNS active therapies

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David L Scott

London, United Kingdom

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • David L Scott

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

August 1, 2006

Study Completion

August 1, 2007

Last Updated

October 2, 2007

Record last verified: 2007-09

Locations

GB(1)