Condition category
Musculoskeletal Diseases
Date applied
25/03/2008
Date assigned
04/07/2008
Last edited
06/08/2010
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 John Eisenhoffer

ORCID ID

Contact details

Purdue Pharma
575 Granite Court
Pickering
Ontario
L1W 3W8
Canada
+1 905 420 6400
medinfo@purdue.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

020-007

Study information

Scientific title

Acronym

Study hypothesis

Study drug 020 will be superior to placebo in the treatment of chronic low back pain.

Ethics approval

Ethics approval for the lead centre was received from the Mount Sinai Hospital Research Ethics Board (REB), Toronto, ON (Canada) on 3rd August 2004. 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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic low back pain

Intervention

Transdermal opioid analgesic (020) titrated to effect over a four-week phase with matched placebo arm, with acetaminophen rescue (325 - 650 mg every four to six hours as and when needed [q4 - 6h prn]) provided in both arms.

Intervention type

Drug

Phase

Not Specified

Drug names

Study drug 020 (buprenorphine transdermal system), acetaminophen

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. Pain and disability
2. Pain and sleep
3. Quality of life
4. Functional disability

Overall trial start date

05/07/2004

Overall trial end date

03/03/2006

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 have not responded adequately to non-opioid analgesics and are currently taking a minimum of one tablet per day of an opioid analgesic

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Patients with intolerance to study drug 020, acetaminophen or any opioid
2. Patients expected to require more than 12 tablets of Tylenol no. 3 per day
3. Patients whose pain is expected to be refractory to opioid therapy
4. Patients who require therapy involving direct external heat sources
5. Patients with a significant source of unrelated pain that may obscure the assessment of efficacy
6. Patients with any of the following medical conditions:
6.1. Renal or hepatic impairment
6.2. Risk of respiratory depression
6.3. Peptic ulcer disease
6.4. Active inflammatory gastrointestinal disease
6.5. Major psychiatric disorder
6.6. Congenital Long QT syndrome, or any family member with this condition
6.7. History of congestive heart failure, atrial fibrillation, myocardial ischaemia, tachycardia (greater than 100 bpm at rest) or bradycardia (less than 45 bmp at rest)
6.8. Decreased serum magnesium or potassium
6.9. Any condition that would obscure patient safety or efficacy assessment
7. Patients currently receiving any of the following:
7.1. Class IA anti-arrhythmic medications (e.g., quinidine, procainamide, disopyramide)
7.2. Class III anti-arrhythmic medications (e.g., sotalol, amiodarone)
7.3. Any medication known to cause torsades de pointes
8. Patients who received an investigational drug within the past month

Recruitment start date

05/07/2004

Recruitment end date

03/03/2006

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

Sponsor type

Industry

Website

http://www.purdue.ca/main/

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20685494

Publication citations

  1. Results

    Gordon A, Callaghan D, Spink D, Cloutier C, Dzongowski P, O'Mahony W, Sinclair D, Rashiq S, Buckley N, Cohen G, Kim J, Boulanger A, Piraino PS, Eisenhoffer J, Harsanyi Z, Darke AC, Michalko KJ, Buprenorphine transdermal system in adults with chronic low back pain: a randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase., Clin Ther, 2010, 32, 5, 844-860, doi: 10.1016/j.clinthera.2010.04.018.

Additional files

Editorial Notes