Condition category
Musculoskeletal Diseases
Date applied
12/06/2008
Date assigned
04/07/2008
Last edited
13/08/2010
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
L1W 3W8
Canada

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

http://www.purdue.ca

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

Publication citations

Additional files

Editorial Notes