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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01582646
Recruitment Status : Terminated (difficulty of recruitment)
First Posted : April 20, 2012
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Postthoracotomy Pain Postthoracoscopy Neuropathic Pain Drug: Terbutaline sustained release 5 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
Actual Study Start Date : January 2012
Primary Completion Date : September 2017
Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582646


Locations
France
CHU de Besançon
Besançon,, France, 25030
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: André Muller, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01582646     History of Changes
Other Study ID Numbers: 4705
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Terbutaline
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action