A randomised, double-blind, crossover comparison of the efficacy and safety of study drug 017 and placebo in patients with neuropathic pain due to diabetic neuropathy (DN) or post-herpetic neuralgia (PHN)
| ISRCTN | ISRCTN33347454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33347454 |
| Protocol serial number | 017-010 |
| Sponsor | Purdue Pharma Canada |
| Funder | Purdue Pharma Canada |
- Submission date
- 25/03/2008
- Registration date
- 04/07/2008
- Last edited
- 04/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Eisenhoffer
Scientific
Scientific
Purdue Pharma
575 Granite Court
Pickerin, Ontario
L1W 3W8
Canada
| Phone | +1 905 420 6400 |
|---|---|
| medinfo@purdue.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centred, randomised, double-blind, placebo-controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Study drug 017 will be superior to placebo in the treatment of chronic neuropathic pain due to diabetic neuropathy (DN) or post-herpetic neuralgia (PHN). |
| Ethics approval(s) | Ethics approval for the lead centre was received from Institutional Review Board (IRB) Services, Aurora, ON (Canada) on 11 January 2008. All other participating centres obtained ethics approval before recruiting study participants. |
| Health condition(s) or problem(s) studied | Neuropathic pain |
| Intervention | Centrally-acting oral opioid anlagesic (017) titrated to effect over a 4-week phase with matched placebo arm. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Study drug 017 (a centrally acting opioid analgesic) |
| Primary outcome measure(s) |
Pain intensity measured during the last week of treatment in each phase. |
| Key secondary outcome measure(s) |
All assessments measured during the last week of treatment in each phase: |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Key inclusion criteria | For diabetic neuropathy patients: 1. Stable glycaemic control 2. Patients with pain in the lower extremities on a daily basis and one or more signs or symptoms of peripheral neuropathy not attributable to any other cause 3. Patients with absent or decreased ankle reflexes and loss of perception of 128 Hz vibration of the great toe For post-herpetic neuralgia patients: 1. Primary diagnosis of PHN defined by pain for at least three months after healing of a herpes zoster skin rash For all patients: 1. Male or non-pregnant females at least 18 years of age 2. Patients who answer yes to at least four items on the the neuropathic pain diagnostic questionnaire (DN4) 3. Patients whose pain has been of moderate intensity on most days for at least three months 4. Patients who have required the use of analgesic medication for at least three months |
| Key exclusion criteria | 1. Patients who do not have stable glycaemic control (HbA1c greater than 2 x normal) or whose anti-diabetic therapy is likely to require adjustment during the study 2. Patients with peripheral neuropathy attributable to other causes 3. Significant pain of other origin that may obscure the assessment of efficacy 4. Patients whose opioid requirement may exceed eight tablets of acetaminophen plus codeine (300/30 mg) or analgesic equivalent per day 5. Patients with true allergy to acetaminophen or any opioid, sufficient that therapy is contraindicated 6. Patients with any of the following medical conditions: 6.1. Active, severe psychiatric disorder, including severe depression 6.2. Postural hypotension 6.3. Clinically significant hepatic dysfunction (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [Alk Phos] greater than 2 x normal) 6.4. Symptomatic coronary artery peripheral vascular disease 6.5. Intermittent claudication 6.6. Brittle diabetes 6.7. Low serum cobalamin (vitamin B12) 6.8. Abnormal serum folic acid levels 6.9. Colostomy, ileostomy or shortened gastrointestinal (GI) transit time 6.10. Active or recent peptic ulcer or gastrointestinal (GI) inflammatory disease 6.11. Epilepsy, history of seizures or recognised risk for seizure 6.12. Any condition that may adversely affect patient safety or obscure assessment of efficacy 7. Patients receiving any of the following medications: 7.1. Monoamine oxidase inhibitors 7.2. Carbamazepine 7.3. Quinidine 7.4. Selective serotonin reuptake inhibitors 7.5. Serotonin norepinephrine reuptake inhibitors 7.6. Neuroleptics 7.7. Warfarin 7.8. Digoxin 8. Patients who have received an investigational drug within the previous month 9. Patients with a known or suspected history of drug or alcohol abuse |
| Date of first enrolment | 21/01/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
Purdue Pharma
Pickerin, Ontario
L1W 3W8
Canada
L1W 3W8
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
