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

NCT ID: NCT00377039

Last Updated: 2007-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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ACR 1990 Fibromyalgia Fibromyalgia Impact Questionnaire

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AD 337

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sosei

INDUSTRY

Sponsor Role lead

Principal Investigators

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David L Scott

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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David L Scott

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AD337-021

Identifier Type: -

Identifier Source: org_study_id