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

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.

Study Overview

• Status: Terminated
• Conditions: Postthoracotomy Pain; Postthoracoscopy Neuropathic Pain
• Intervention / Treatment: Drug: Terbutaline sustained release 5 mg

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Besançon,, France, 25030
    • CHu de Besançon
  • Strasbourg, France, 67091
    • Hopitaux Universitaires De Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale	Day one, day 14 and day 28 of each 4 weeks period

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: André Muller, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Terbutaline
• Other Study ID Numbers: 4705