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Imipramine and Pregabalin Combination in Painful Polyneuropathy

O

Odense University Hospital

Status and phase

Unknown
Phase 4

Conditions

Polyneuropathy

Treatments

Drug: Placebo
Drug: Imipramine, pregabalin
Drug: Imipramine
Drug: Pregabalin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01047488
tcapgbcomb1
2009-013642-80 (EudraCT Number)

Details and patient eligibility

About

Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.

This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.

Enrollment

75 estimated patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 20 - 85 years.
  • Characteristic symptoms of polyneuropathy for at least 6 months.
  • Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
  • Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
  • Pain present at least 4 days a week.
  • For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months.
  • For other secondary polyneuropathies: stable for at least 6 months.
  • For fertile females: adequate anticonceptive treatment.
  • Written informed consent.

Exclusion criteria

  • Other cause of pain.
  • Contraindications against imipramine.
  • Allergic reactions towards imipramine or pregabalin.
  • Known adverse reactions during imipramine or pregabalin treatment.
  • Pregnancy.
  • Severe systemic disease.
  • Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor.
  • Inability to follow study protocol.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

75 participants in 4 patient groups, including a placebo group

Imipramine
Active Comparator group
Description:
Imipramine tablets and placebo capsules to pregabalin
Treatment:
Drug: Imipramine
Pregabalin
Active Comparator group
Description:
Pregabalin capsules and placebo tablets to imipramine
Treatment:
Drug: Pregabalin
Imipramine plus pregabalin
Experimental group
Description:
Imipramine tablets and pregabalin capsules
Treatment:
Drug: Imipramine, pregabalin
Placebo
Placebo Comparator group
Description:
Placebo tablets to imipramine and placebo capsules to pregabalin
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Central trial contact

Søren H. Sindrup, MD; Jakob V. Holbech, MD

Data sourced from clinicaltrials.gov

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