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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01047488
Other study ID # tcapgbcomb1
Secondary ID 2009-013642-80
Status Not yet recruiting
Phase Phase 4
First received January 12, 2010
Last updated January 12, 2010
Start date February 2010
Est. completion date March 2013

Study information

Verified date January 2010
Source Odense University Hospital
Contact Søren H. Sindrup, MD
Phone +45 65412471
Email soeren.sindrup@ouh.regionsyddanmark.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Imipramine
Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks
Pregabalin
Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
Imipramine, pregabalin
Imipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
Placebo
Placebo tablets to imipramine 25 mg, 3 or 1 tablet evening, daily, 5 weeks Placebo capsules to pregabalin 75 mg, 2 capsules daily, daily, 5 weeks

Locations

Country Name City State
Denmark Department of Neurology, Aalborg Hospital Aalborg
Denmark Department of Neurology, Aarhus University Hospital Århus
Denmark Department of Neurology, Odense University Hospital Odense

Sponsors (3)

Lead Sponsor Collaborator
Odense University Hospital Nycomed, Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total pain intensity as measured by numeric rating scale 0-10 points. Median of ratings from last week of each treatment period No
Secondary Verbal pain relief scale with 6 classes End of each treatment period No
Secondary Specific pain symptom rated by numeric rating scales 0-10 points Median of ratings from last week of each treatment period No
Secondary Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points End of each treatment period No
Secondary Sleep disturbance as measured by numeric rating scale 0-10 points Median of ratings from last week of each treatment period No
Secondary Consumption of escape medication (number of tablets of paracetamol) Total consumption during last week of each treatment period No
Secondary Health related quality of life (SF-36) End of each treatment period No
Secondary Major Depression Inventory (MDI) End of each treament period No
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