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

September 30, 2007 updated by: Sosei

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sosei

Investigators

  • Principal Investigator: David L Scott, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 14, 2006

First Submitted That Met QC Criteria

September 14, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 2, 2007

Last Update Submitted That Met QC Criteria

September 30, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD337-021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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