Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT00757679
First received: September 22, 2008
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Fibromyalgia Syndrome
Drug: Milnacipran
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • The safety/tolerability and compliance of 8 weeks of treatment with milnacipran [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran Drug: Milnacipran
capsules
Placebo Comparator: Placebo Drug: Placebo
capsules

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757679

Locations
Switzerland
Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre
Geneve, Switzerland
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
Principal Investigator: Jules Desmeules, MD Centre Hospitalier HUG Genève - SUISSE
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT00757679     History of Changes
Other Study ID Numbers: F02207 GE 205
Study First Received: September 22, 2008
Last Updated: July 10, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics
Milnacipran
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on April 17, 2014