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
Secondary identifying numbers	017-010

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

Purdue Pharma
575 Granite Court
Pickerin, Ontario
L1W 3W8
Canada

Phone	+1 905 420 6400
Email	medinfo@purdue.ca

Study information

Study design	Multi-centred, randomised, double-blind, placebo-controlled crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format. Please have your family physician use the contact details below to request information on the study.
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Study drug 017 (a centrally acting opioid analgesic)
Primary outcome measure	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 study start date	21/01/2008
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

Purdue Pharma Canada
Industry

575 Granite Court
Pickering, Ontario
L1W 3W8
Canada

Website	http://www.purdue.ca/main/
"ROR"	https://ror.org/023sxys58

Funders

Funder type

Industry

Purdue Pharma Canada

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan