Condition category
Nervous System Diseases
Date applied
31/08/2004
Date assigned
31/08/2004
Last edited
16/10/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Gilron

ORCID ID

Contact details

Queen's University
76 Stuart Street
Victory 2
Kingston
ON
K7L 2V7
Canada
gilroni@post.queensu.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-69422

Study information

Scientific title

Acronym

Study hypothesis

The central hypothesis is that a combination of nortriptyline and gabapentin has a superior therapeutic profile than that of either drug alone.

Ethics approval

This trial has been review and approved by the Queen's University Research Ethics Board.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Neuropathic pain

Intervention

Oral administration of:
1. Gabapentin
2. Nortriptyline
3. A gabapentin-nortriptyline combination

The end date of this trial is still being discussed, the anticipated end date entered above is an arbitrary date entered as one year after the trial started.

Intervention type

Drug

Phase

Not Specified

Drug names

Gabapentin, nortriptylin

Primary outcome measures

The primary outcome measure of this study will be the mean daily pain intensity from the last seven days, at maximal tolerated dose, of each treatment period.

Secondary outcome measures

Secondary outcome measures will include frequency and severity of treatment-emergent adverse effects, global pain relief ratings, the short form McGill Pain Questionnaire, a pain interference questionnaire (Brief Pain Inventory), consumption of rescue medication (number of acetaminophen 325 mg tablets), a blinding questionnaire, two mood questionnaires (Beck Depression Inventory and Profile of Mood States) and a quality of life survey (SF-36).

Overall trial start date

01/11/2004

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diabetic patients of either sex
2. 18 to 89 years of age
3. Distal, symmetric, sensory polyneuropathy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

71

Participant exclusion criteria

1. Neuropathy attributable to an etiology other than diabetes (e.g. hypothyroidism, vitamin B12 deficiency, connective tissue disease, amyloidosis and toxic exposure)
2. Presence of a painful condition as severe as, but distinct from, their diabetic neuropathy pain
3. Pregnancy or lactation
4. End-stage kidney or liver disease
5. Moderate to severe heart disease (Myocardial Infarction [MI] within preceding year, unstable angina, cardiac conduction defect or congestive heart failure)
6. Cardiovascular autonomic neuropathy
7. Postural hypotension more than 20 mmHg on initial assessment
8. Baseline mild to severe sedation or ataxia due to required concomitant drugs, or any other cause
9. Males with urinary symptoms attributable to benign prostatic hypertrophy
10. Presence of a seizure disorder
11. Angle-closure glaucoma
12. Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist
13. Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g. carbamazepine, oxcarbazepine)
14. Hypersensitivity to any of the study medications
15. History of significant abuse of illicit drugs, prescription drugs or alcohol
16. Lack of a primary physician
17. Patients who live alone and cannot assure daily contact with a friend, family member or caregiver

Recruitment start date

01/11/2004

Recruitment end date

01/11/2005

Locations

Countries of recruitment

Canada

Trial participating centre

Queen's University
Kingston, ON
K7L 2V7
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
Ontario
K1A OW9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-69422)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19796802

Publication citations

  1. Results

    Gilron I, Bailey JM, Tu D, Holden RR, Jackson AC, Houlden RL, Nortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trial., Lancet, 2009, 374, 9697, 1252-1261, doi: 10.1016/S0140-6736(09)61081-3.

Additional files

Editorial Notes