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

ISRCTN ISRCTN35931095
DOI https://doi.org/10.1186/ISRCTN35931095
Secondary identifying numbers 038-001
Submission date
12/06/2008
Registration date
04/07/2008
Last edited
13/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
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
L1W 3W8
Canada

Study information

Study designMulti-centred, randomised, double-blind, placebo-controlled 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 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) studiedChronic low back pain
InterventionOral opioid analgesic (038) titrated to effect over a four-week phase with matched placebo arm.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Study drug 038
Primary outcome measurePain intensity 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. Quebec Back Pain
2. Pain and sleep
3. Pain and disability
4. Quality of life
5. Bowel function
Overall study start date01/12/2006
Completion date30/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2006
Date of final enrolment30/04/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

Purdue Pharma
Pickering
L1W 3W8
Canada

Sponsor information

Purdue Pharma Canada
Industry

c/o Dr. John Eisenhoffer
575 Granite Court
Pickering
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

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