A randomised, crossover study of study drug 038 and controlled-release oxycodone HCl tablets in patients with chronic non-cancer pain

ISRCTN ISRCTN76170309
DOI https://doi.org/10.1186/ISRCTN76170309
Secondary identifying numbers 038-002
Submission date
09/12/2008
Registration date
08/01/2009
Last edited
10/01/2011
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

Not provided at time of registration

Contact information

Dr Paula Piraino
Scientific

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

Phone +1 905 420 6400
Email paula.piraino@purdue.ca

Study information

Study designMulticentre randomised double-blind crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
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 objectivesStudy drug 038 will be superior to controlled-release (CR) oxycodone on bowel function and not inferior to CR oxycodone in pain control in patients with chronic non-cancer pain.

As of 13/08/2010 this record was updated to include an extended end date; the initial anticipated end date at the time of registration was 15/09/2009.

As of 10/01/2011 this record was again updated to include an extended end date; the previous anticipated end date at the time of registration was 31/03/2011.
Ethics approval(s)Lead centre received approval from IRB Services, Aurora, Ontario (Canada) on 10 June 2008
Health condition(s) or problem(s) studiedChronic non-cancer pain and bowel function
InterventionOral opioid analgesic (038) titrated to effect over a five-week phase with matched CR oxycodone arm.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Study drug 038, controlled-release oxycodone HCl
Primary outcome measurePain intensity and bowel function measured during the last week of treatment in each phase.
Secondary outcome measuresAll assessments measured during the last week of treatment in each phase:
1. ROME-III
2. Patient Assessment of Constipation Symptoms (PAC-SYM)
3. Brief Pain Inventory
4. Multidimensional Pain Inventory
5. Beck Depression Inventory
6. Pain Disability Index
7. Pain and Sleep Questionnaire
8. Level of Activity
Overall study start date31/07/2008
Completion date31/03/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteria1. Male or non-pregnant, non-nursing female patients over the age of 18 years with chronic non-cancer pain of moderate or greater intensity for at least three months
2. Patients who require stable doses of 60 to 80 mg every 12 hours of oxycodone or its analgesic equivalent
3. Patients experiencing less than three complete, spontaneous bowel movements in the seven days prior to randomisation
Key exclusion criteria1. Patients who undergoing any treatments that may change their pain during the study, such as physiotherapy, corticosteroid injections or surgical procedures
2. Patients who do not respond adequately to doses of 60 or 80 mg every 12 hours of oxycodone
3. Patients whose pain is expected to be refractory to continuous opioid therapy
4. Patients with allergy to study drug 038, oxycodone or any other opioid
5. Patients with any of the following:
5.1. A condition that affects patient safety or obscures the assessment of efficacy
5.2. Compromised kidney or liver function
5.3. Risk for central nervous system (CNS) and/or respiratory depression
5.4. Significant gastrointestinal structural abnormalities or diseases/conditions that affect bowel function
5.5. A major psychiatric disorder
5.6. Received an investigational drug in the last month
5.7. Failed the urine drug screen
Date of first enrolment31/07/2008
Date of final enrolment31/03/2012

Locations

Countries of recruitment

  • Canada

Study participating centre

Purdue Pharma
Pickering, Ontario
L1W 3W8
Canada

Sponsor information

Purdue Pharma Canada
Industry

575 Granite Court
Pickering, Ontario
L1W 3W8
Canada

Phone +1 905 420 6400
Email medinfo@purdue.ca
Website http://www.purdue.ca
ROR logo "ROR" https://ror.org/023sxys58

Funders

Funder type

Industry

Purdue Pharma Canada (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan