Contact information
Type
Scientific
Primary contact
Dr Paula Piraino
ORCID ID
Contact details
Purdue Pharma
575 Granite Court
Pickering
Ontario
L1W 3W8
Canada
+1 905 420 6400
paula.piraino@purdue.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
038-002
Study information
Scientific title
Acronym
Study hypothesis
Study 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
Lead centre received approval from IRB Services, Aurora, Ontario (Canada) on 10 June 2008
Study design
Multicentre randomised double-blind crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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
Chronic non-cancer pain and bowel function
Intervention
Oral opioid analgesic (038) titrated to effect over a five-week phase with matched CR oxycodone arm.
Intervention type
Drug
Phase
Phase III
Drug names
Study drug 038, controlled-release oxycodone HCl
Primary outcome measures
Pain intensity and bowel function 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. 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 trial start date
31/07/2008
Overall trial end date
31/03/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. 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
Recruitment start date
31/07/2008
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Canada
Trial participating centre
Purdue Pharma
Pickering, Ontario
L1W 3W8
Canada
Sponsor information
Organisation
Purdue Pharma Canada
Sponsor details
575 Granite Court
Pickering
Ontario
L1W 3W8
Canada
+1 905 420 6400
medinfo@purdue.ca
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Purdue Pharma Canada (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