Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

• Sponsor: Napp Pharmaceuticals Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00324038
• Collaborator: (none)
• Enrollment: 219
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Buprenorphine; Drug: Codeine paracetamol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: buprenorphine transdermal system Buprenorphine transdermal 7 day analgesic patch	Drug: Buprenorphine; buprenorphine transdermal system 5, 10 and 20 mg; Other Names: BuTrans/Norspan
Active Comparator: codeine paracetamol tablets codeine paracetamol combination tablets	Drug: Codeine paracetamol; combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500; Other Names: Co-codamol tablets

Outcome Measures

Primary Outcome Measures

1. Average Daily Pain Scores - BS11 Pain Scores. [every day over a 12 week study duration.]

   The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Either sex aged 65 or above

• Diagnosis of OA of the hip and/or knee

• Severe pain requiring step two medication

• Taking maximum dose of paracetamol

Exclusion Criteria:

• Painful disease of the joints other than OA

• Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)

• Subjects taking cyclooxygenase (COX) II selective inhibitors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Napp Pharmaceuticals Ltd	Cambridge		United Kingdom	CB4 0GW

Sponsors and Collaborators

• Napp Pharmaceuticals Limited

Investigators

• Principal Investigator: Prof Philip Conaghan,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00324038
• Other Study ID Numbers: 2005-004279-39; BUP4004
• First Posted: May 10, 2006
• Last Update Posted: Jun 14, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: OA; Elderly; Pain; OA of the hips and/or knees
• Additional relevant MeSH terms: Osteoarthritis; Acetaminophen; Buprenorphine; Codeine

Study Results

Participant Flow

Recruitment Details	Primary care. March 2006 to Aug 2007
Pre-assignment Detail	Screening for patient eligibility

Arm/Group Title	Buprenorphine Transdermal System	Co-codamol Tablets
Arm/Group Description	Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days	combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Period Title: Overall Study
STARTED	110	109
COMPLETED	61	58
NOT COMPLETED	49	51

Baseline Characteristics

Arm/Group Title	Buprenorphine Transdermal System	Co-codamol Tablets	Total
Arm/Group Description	Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days	combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500	Total of all reporting groups
Overall Participants	110	109	219
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 18.2%	23 21.1%	43 19.6%
>=65 years	90 81.8%	86 78.9%	176 80.4%
Sex: Female, Male (Count of Participants)
Female	75 68.2%	74 67.9%	149 68%
Male	35 31.8%	35 32.1%	70 32%

Outcome Measures

1. Primary Outcome

Title	Average Daily Pain Scores - BS11 Pain Scores.
Description	The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
Time Frame	every day over a 12 week study duration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buprenorphine Transdermal System	Co-codamol Tablets
Arm/Group Description	Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days	combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Measure Participants	61	58
Mean (Standard Deviation) [Box Scale 11 boxes]	3 (1.31)	3 (1.1)

Adverse Events

Adverse Event Reporting Description	Serious and non serious adverse events were collected/assessed but not serious adverse events
Arm/Group Title	Buprenorphine Transdermal System		Co-codamol Tablets
Arm/Group Description	Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days		combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
All Cause Mortality
	Buprenorphine Transdermal System		Co-codamol Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Buprenorphine Transdermal System		Co-codamol Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Buprenorphine Transdermal System		Co-codamol Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.