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

Postthoracoscopy Neuropathic Pain Clinical Trial

— Bêtapain  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01582646
• Other study ID #: 4705
• Status: Terminated
• Phase: Phase 2
• First received: April 10, 2012
• Last updated: September 7, 2017
• Start date: January 2012
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-blockers, tricyclic ADs or morphine

• concomitant pain more severe than neuropathic pain- pregnant women

Related Conditions & MeSH terms

• Neuralgia
• Postthoracoscopy Neuropathic Pain
• Postthoracotomy Pain

Intervention

Drug:
• Terbutaline sustained release 5 mg
Terbutaline 10mg oral per day (5 mg twice a day) during 28 days

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon,
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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