Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
038-001
Study information
Scientific title
Acronym
Study hypothesis
Study drug 038 will be superior to placebo on the treatment of chronic low back pain.
Ethics approval
Ethics approval for the lead centre was received from IRB Services, Aurora, Ontario (Canada) on December 1, 2006. 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
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 low back pain
Intervention
Oral opioid analgesic (038) titrated to effect over a four-week phase with matched placebo arm.
Intervention type
Drug
Phase
Not Specified
Drug names
Study drug 038
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. Quebec Back Pain
2. Pain and sleep
3. Pain and disability
4. Quality of life
5. Bowel function
Overall trial start date
01/12/2006
Overall trial end date
30/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or non-pregnant females at least 18 years of age
2. Chronic low back pain of at least moderate intensity for at least three months
3. Patients who require opioids to control their pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients who may require more than 12 tables of Tylenol No. 3 per day
2. Patients whose pain is expected to be refractory to opioid therapy
3. Patients with intolerance to study drug 038, acetaminophen or any other opioid
4. Patients with significant sources of unrelated pain that may obscure the assessment of efficacy
5. Patients with any of the following medical conditions:
5.1. Risk for central nervous system (CNS) and/or respiratory depression
5.3. Active inflammatory gastrointestinal disease
5.4. Peptic ulcer disease
5.5. Major psychiatric disorder
5.6. Any condition that may obscure patient safety or efficacy assessment
5.7. Patients who have received an investigational drug within the last month
Recruitment start date
01/12/2006
Recruitment end date
30/04/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Purdue Pharma
Pickering
L1W 3W8
Canada
Sponsor information
Organisation
Purdue Pharma Canada
Sponsor details
c/o Dr. John Eisenhoffer
575 Granite Court
Pickering
L1W 3W8
Canada
+1 905 420 6400
medinfo@purdue.ca
Sponsor type
Industry
Website
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