Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

NCT ID: NCT00757679

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-09-30

Brief Summary

Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients

Conditions

Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Milnacipran

Group Type: EXPERIMENTAL

Milnacipran

Intervention Type: DRUG

capsules

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsules

Interventions

Milnacipran

capsules

Intervention Type: DRUG

Placebo

capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patient with FMS according to the 1990 ACR criteria
• patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates
• patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics

Exclusion Criteria

• severe psychiatric illness
• current Major Depressive Episode (MDE)
• significant risk of suicide
• history of substance abuse
• epilepsy
• myocardial infarction in the past 24 months
• active cardiac disease
• congestive heart failure
• prosthetic heart valve
• haemodynamically significant valvular heart disease
• known cardiac rhythm anomalies or conduction abnormalities
• unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmHg
• pulmonary dysfunction
• active liver disease
• renal impairment
• documented autoimmune disease
• current systemic infection
• active cancer, except basal cell carcinoma or current cancer therapy
• severe sleep apnoea
• active peptic ulcer or inflammatory bowel disease (except IBS)
• unstable endocrine disease
• pregnancy or breastfeeding
• concomitant use of non selective MAO inhibitors, MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs, NARIs, SNRIs, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines
• concomitant use of oral anticoagulants, anticonvulsants, type Ic antiarrythmics, lithium
• concomitant use of hypericum and SAMe
• concomitant use of digitalis preparations
• regular use of centrally-acting muscle relaxants
• concomitant use of strong analgesics, including tramadol, codeine or opiates
• any factor known to affect the HPA axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jules Desmeules, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier HUG Genève - SUISSE

Locations

Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

F02207 GE 205

Identifier Type: -

Identifier Source: org_study_id