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

Phase 2

Terminated

• Conditions: Postthoracotomy Pain; Postthoracoscopy Neuropathic Pain
• Interventions: Drug: Terbutaline sustained release 5 mg

• Registration Number: NCT01582646
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
first period with placebo and second period with terbutaline.	Terbutaline sustained release 5 mg	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.
first period with terbutaline and second period with placebo	Terbutaline sustained release 5 mg	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CHU de Besançon; 🇫🇷 Besançon,, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France