Condition category
Signs and Symptoms
Date applied
09/12/2008
Date assigned
08/01/2009
Last edited
10/01/2011
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 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

http://www.purdue.ca

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

Publication citations

Additional files

Editorial Notes