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

NCT01582646 | Terminated Phase 2

• 1 other identifier: 4705
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Postthoracotomy Pain; Postthoracoscopy Neuropathic Pain

Outcome Measures

Primary Outcomes (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

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

Study Arms (2)

first period with terbutaline and second period with placebo

OTHER

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

first period with placebo and second period with terbutaline.

OTHER

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

Interventions

Terbutaline sustained release 5 mg DRUG

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

first period with placebo and second period with terbutaline.; first period with terbutaline and second period with placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults from 18 to 75 years old
• neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (2)

CHU de Besançon

Besançon, 25030, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

• André Muller, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 20, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

FR (2)