Back to resultsAnalgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain (Bêtapain)
Primary Purpose
Postthoracotomy Pain, Postthoracoscopy Neuropathic Pain
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Terbutaline sustained release 5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Postthoracotomy Pain
Eligibility 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
Sites / Locations
- CHU de Besançon
- Hôpitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
first period with terbutaline and second period with placebo
first period with placebo and second period with terbutaline.
Arm Description
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.
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.
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01582646
First Posted
April 10, 2012
Last Updated
September 7, 2017
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01582646
Brief Title
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
Acronym
Bêtapain
Official Title
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
difficulty of recruitment
Study Start Date
January 2012 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postthoracotomy Pain, Postthoracoscopy Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
first period with terbutaline and second period with placebo
Arm Type
Other
Arm Description
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.
Arm Title
first period with placebo and second period with terbutaline.
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Terbutaline sustained release 5 mg
Intervention Description
Terbutaline 10mg oral per day (5 mg twice a day) during 28 days
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Muller, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon,
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
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