search
Back to results

A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

Primary Purpose

Fibromyalgia Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
milnacipran
Placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

  • psychiatric illness
  • depression of generalised anxiety disorder
  • suicidal risk
  • substance abuse
  • active cardiac disease
  • pulmonary dysfunction
  • liver disease
  • renal impairment
  • autoimmune disease
  • chronic inflammatory rheumatoid disease
  • current systemic infection
  • epileptic
  • active cancer
  • sleep apnea
  • active peptic ulcer
  • inflammatory bowel disease
  • unstable endocrine disease
  • for men : prostatic enlargement of genito-urinary disorders
  • for women : pregnancy or breast feeding

Sites / Locations

  • Rheumatology Ambulance
  • FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
  • Kuopion Oma Laakari Oy
  • Hopital Hotel Dieu
  • KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
  • Ospedale Luigi Sacco
  • Center For Clinical Studies
  • "Nasz Lekarz"
  • Hospital Egas Moniz
  • Dr I CANTACUZINO CLINICAL HOSPITAL
  • Hospital de La Esperanza
  • Gottfriesclinic Ab
  • KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Minalcipran

Arm Description

Outcomes

Primary Outcome Measures

To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion

Secondary Outcome Measures

comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria
establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).

Full Information

First Posted
February 15, 2007
Last Updated
July 10, 2013
Sponsor
Pierre Fabre Medicament
search

1. Study Identification

Unique Protocol Identification Number
NCT00436033
Brief Title
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
Official Title
A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. Study Description

Brief Summary
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Minalcipran
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
milnacipran
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria
Time Frame
12 weeks
Title
establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).
Time Frame
19 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria Exclusion Criteria: psychiatric illness depression of generalised anxiety disorder suicidal risk substance abuse active cardiac disease pulmonary dysfunction liver disease renal impairment autoimmune disease chronic inflammatory rheumatoid disease current systemic infection epileptic active cancer sleep apnea active peptic ulcer inflammatory bowel disease unstable endocrine disease for men : prostatic enlargement of genito-urinary disorders for women : pregnancy or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Jaime C BRANCO
Organizational Affiliation
HOSPITAL EGAS MONIZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Ambulance
City
Pardubice
ZIP/Postal Code
530 02
Country
Czech Republic
Facility Name
FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
City
Frederiksberg
ZIP/Postal Code
F2000
Country
Denmark
Facility Name
Kuopion Oma Laakari Oy
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Hopital Hotel Dieu
City
Paris
Country
France
Facility Name
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
City
Koln
ZIP/Postal Code
D50931
Country
Germany
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Center For Clinical Studies
City
Lillehamer
ZIP/Postal Code
2609
Country
Norway
Facility Name
"Nasz Lekarz"
City
Torun
Country
Poland
Facility Name
Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Dr I CANTACUZINO CLINICAL HOSPITAL
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Hospital de La Esperanza
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Gottfriesclinic Ab
City
Molndal
ZIP/Postal Code
43137
Country
Sweden
Facility Name
KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology
City
London
ZIP/Postal Code
SE59RJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20156949
Citation
Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.
Results Reference
derived

Learn more about this trial

A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

We'll reach out to this number within 24 hrs