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

September 7, 2017 updated by: University Hospital, Strasbourg, France
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon,, France, 25030
        • CHU de Besançon
      • Strasbourg, France, 67091
        • Hôpitaux universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day one, day 14 and day 28 of each 4 weeks period
Day one, day 14 and day 28 of each 4 weeks period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 4705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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