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Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain (Bêtapain)

This study is currently recruiting participants.
Verified April 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01582646
First received: April 10, 2012
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.


Condition Intervention Phase
Postthoracotomy Pain
Postthoracoscopy Neuropathic Pain
 Drug: Terbutaline sustained release 5 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale [ Time Frame: Day one, day 14 and day 28 of each 4 weeks period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
first period with terbutaline and second period with placebo
The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods.
 Drug: Terbutaline sustained release 5 mg
Terbutaline 10mg oral per day (5 mg twice a day) during 28 days
first period with placebo and second period with terbutaline.
The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods.
 Drug: Terbutaline sustained release 5 mg
Terbutaline 10mg oral per day (5 mg twice a day) during 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults from 18 to 75 years old
  • neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months

Exclusion criteria:

  • cardiovascular risk
  • unstable diabetes mellitus
  • allergy for terbutaline
  • hypokaliemia without treatment
  • untreated hypothyroidism
  • HIV- or chemotherapy-induced neuropathy
  • cancer being treated by chemo- or radio-therapy
  • concomitant treatment with β-blockers, tricyclic ADs or morphine
  • concomitant pain more severe than neuropathic pain- pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582646

Contacts
Contact: Eric Salvat, MD 03 88 11 57 65 ext 0033 eric.salvat@chru-strasbourg.fr

Locations
France
CHU de Besançon Not yet recruiting
Besançon,, France, 25030
Contact: Florence TIBERGHIEN-CHATELAIN, MD     03 81 66 85 09 ext 0033     ftiberghien@chu-besancon.fr    
Principal Investigator: Jean-Louis Lajoie, MD            
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Eric Salvat, MD     03 88 11 57 65 ext 0033     eric.salvat@chru-strasbourg.fr    
Principal Investigator: André Muller, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: André Muller, MD University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01582646     History of Changes
Other Study ID Numbers: 4705
Study First Received: April 10, 2012
Last Updated: April 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Terbutaline
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013