Analgesic Drug Combinations in Neuropathic Pain (2004)
| ISRCTN | ISRCTN73178636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73178636 |
| Protocol serial number | MCT-69422 |
| Sponsor | Canadian Institutes of Health Research (CIHR) (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-69422) |
- Submission date
- 31/08/2004
- Registration date
- 31/08/2004
- Last edited
- 16/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Gilron
Scientific
Scientific
Queen's University
76 Stuart Street
Victory 2
Kingston, ON
K7L 2V7
Canada
| gilroni@post.queensu.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The central hypothesis is that a combination of nortriptyline and gabapentin has a superior therapeutic profile than that of either drug alone. |
| Ethics approval(s) | This trial has been review and approved by the Queen's University Research Ethics Board. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Gabapentin, nortriptylin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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). |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 71 |
| Key inclusion criteria | 1. Diabetic patients of either sex 2. 18 to 89 years of age 3. Distal, symmetric, sensory polyneuropathy |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Queen's University
Kingston, ON
K7L 2V7
Canada
K7L 2V7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/10/2009 | Yes | No |
