A randomised, placebo-controlled, titration-to-effect, crossover study of study drug 038 in patients with chronic low back pain

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

Dr Paula Piraino
Scientific

Purdue Pharma
575 Granite Court
Pickering
L1W 3W8
Canada

Primary study design	Interventional
Study design	Multi-centred, randomised, double-blind, placebo-controlled crossover trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Study drug 038 will be superior to placebo on the treatment of chronic low back pain.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Study drug 038
Primary outcome measure(s)	Pain intensity measured during the last week of treatment in each phase.
Key secondary outcome measure(s)	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
Completion date	30/04/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	30/04/2008

Purdue Pharma

Pickering
L1W 3W8
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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