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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postthoracotomy Pain Postthoracoscopy Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Terbutaline sustained release 5 mg

Intervention Type DRUG

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.

Group Type OTHER

Terbutaline sustained release 5 mg

Intervention Type DRUG

Terbutaline 10mg oral per day (5 mg twice a day) during 28 days

Interventions

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Terbutaline sustained release 5 mg

Terbutaline 10mg oral per day (5 mg twice a day) during 28 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No