Study of PRC-062 in patients with chronic non-cancer pain

ISRCTN	ISRCTN54273961
DOI	https://doi.org/10.1186/ISRCTN54273961
Protocol serial number	062-010
Sponsor	Purdue Pharma (Canada)
Funder	Purdue Pharma (Canada)

Submission date: 11/11/2013
Registration date: 20/12/2013
Last edited: 20/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The purpose of this study is to see if a drug called PRC-062 works as well as the drug named CR hydromorphone in treating chronic non-cancer pain.

Who can participate?
Adults taking CR hydromorphone for the treatment of chronic non-cancer pain for at least 3 months can participate in this study.

What does the study involve?
The study has two phases. In the first phase all participants will receive CR hydromorphone. In the second phase participants will be randomly allocated to receive either CR hydromorphone or PRC-062. They will be followed up at their clinic visits.

What are the possible benefits and risks of participating?
Participation in this study will provide important information on the safety and effectiveness of PRC-062, which may benefit other patients with chronic pain. The main risks are expected to be similar to those associated with the regular use of CR hydromorphone.

Where is the study run from?
The study is run in clinics located in Canada.

When is the study starting and how long is it expected to run for?
The study started in November 2013 and is expected to run for approximately one year.

Who is funding the study?
Purdue Pharma, Canada.

Who is the main contact?
Purdue Pharma Product Information
productinfo@purdue.ca

Contact information

Dr David Thompson
Scientific

575 Granite Court
Pickering, Ontario
L1W 3W8
Canada

Study information

Primary study design	Interventional
Study design	Multicenter randomized double-blind active-controlled parallel arm study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Phase III, randomized, double-blind, active-controlled, parallel arm study of PRC-062 in patients with chronic non-cancer pain
Study objectives	PRC-062 at equal doses is as effective as CR hydromorphone in maintaining pain control in subjects with stable chronic non-cancer pain.
Ethics approval(s)	Institutional Review Board (IRB) Services, Aurora, Ontario, Canada, 11/09/2013
Health condition(s) or problem(s) studied	Chronic non-cancer pain
Intervention	The duration of the study is six weeks. In the first phase all subjects will receive CR hydromorphone. In the second phase, subjects will be randomized to receive either CR hydromorphone or PRC-062 and will be followed-up at weekly clinic visits.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	PRC-062, CR hydromorphone
Primary outcome measure(s)	Proportion of subjects in each arm who require a dose change from their pre-randomization CR hydromorphone dose, irrespective of when during the post-randomization period this dose change occurs
Key secondary outcome measure(s)	1. Magnitude of the mean dose change between treatment arms 2. Within-subject magnitude of the dose change from pre- to post-randomization 3. Rescue medication usage 4. Pain Intensity Questionnaire (PIQ), at weekly visits during the study 5. Beck Depression Inventory (BDI), at weekly visits during the study 6. Pain and Sleep Questionnaire 3 Item Index (PSQ-3), at weekly visits during the study 7. Pain and Disability Index (PDI), at weekly visits during the study 8. Treatment effectiveness and satisfaction, at weekly visits during the study 9. Global Impression of Change (GIC) scale, at weekly visits during the study 10. Subjective Opiate Withdrawal Scale (SOWS), at weekly visits during the study 11. Quality of life (SF-12) questionnaire, at weekly visits during the study 12. Brief Pain Inventory (BPI), at weekly visits during the study 13. Bowel Function Index (BFI), at weekly visits during the study 14. Laxative use The secondary endpoints of magnitude of the mean dose change between treatment arms, the within-subject magnitude of the dose change from pre- to post-randomization, laxative use and rescue medication use will be captured irrespective of when during the post-randomization period these changes occur. The mean change from baseline in all endpoints will be measured.
Completion date	31/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key inclusion criteria	1. Male or non-pregnant, non-nursing female subjects of 18 years of age or older 2. History of chronic non-cancer pain for six months or more 3. Subjects who at time of screening require stable doses of CR hydromorphone not exceeding 60 mg per day for a period of three months or more prior to entry into the study and who report satisfaction with their pain management
Key exclusion criteria	1. Subjects who do not respond adequately to on-label dosing of CR hydromorphone at doses not exceeding 60 mg per day 2. Subjects with cancer 3. Inhaled cannabis use 4. Compromised kidney or liver function 5. Conditions that may adversely affect safety or obscure the assessment of efficacy 6. Risk for central nervous system (CNS) or respiratory depression 7. Significant gastrointestinal (GI) structural abnormalities or diseases/conditions that may affect bowel function 8. Major psychiatric disorder 9. Received an investigational drug in the past month 10. Taking monoamine oxidase (MAO) inhibitors
Date of first enrolment	01/11/2013
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

Canada

Study participating centre

575 Granite Court

Pickering, Ontario
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