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
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
-
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.