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

This study is currently recruiting participants. (see Contacts and Locations)
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: September 17, 2014
Last verified: April 2012
  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:


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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 17, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 23, 2014