Contact information
Type
Scientific
Primary contact
Dr John Eisenhoffer
ORCID ID
Contact details
Purdue Pharma
575 Granite Court
Pickerin
Ontario
L1W 3W8
Canada
+1 905 420 6400
medinfo@purdue.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
017-010
Study information
Scientific title
Acronym
Study hypothesis
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
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.
Study design
Multi-centred, randomised, double-blind, placebo-controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format. Please have your family physician use the contact details below to request information on the study.
Condition
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 names
Study drug 017 (a centrally acting opioid analgesic)
Primary outcome measures
Pain intensity measured during the last week of treatment in each phase.
Secondary outcome measures
All assessments measured during the last week of treatment in each phase:
1. Neuropathic Pain Scale
2. Pain and sleep
3. Pain and disability
4. Quality of life
5. Depression inventory
Overall trial start date
21/01/2008
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant 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
Recruitment start date
21/01/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Purdue Pharma
Pickerin, Ontario
L1W 3W8
Canada
Sponsor information
Organisation
Purdue Pharma Canada
Sponsor details
575 Granite Court
Pickering
Ontario
L1W 3W8
Canada
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Purdue Pharma Canada
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