Condition category
Nervous System Diseases
Date applied
25/03/2008
Date assigned
04/07/2008
Last edited
04/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.purdue.ca/main/

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

Publication citations

Additional files

Editorial Notes