Trial Outcomes & Findings for Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly (NCT NCT00324038)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

219 participants

Primary outcome timeframe

every day over a 12 week study duration.

Results posted on

2011-06-14

Participant Flow

Primary care. March 2006 to Aug 2007

Screening for patient eligibility

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	Buprenorphine Transdermal System Buprenorphine transdermal system (patch)5mg, 10mg \& 20mg worn for 7 days	Co-codamol Tablets combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Overall Study Adverse Event	38	23
Overall Study Lack of Efficacy	5	13
Overall Study Lost to Follow-up	0	2
Overall Study Other	6	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine Transdermal System n=110 Participants Buprenorphine transdermal system (patch)5mg, 10mg \& 20mg worn for 7 days	Co-codamol Tablets n=109 Participants 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 n=219 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	90 Participants n=5 Participants	86 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	74 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Buprenorphine Transdermal System n=61 Participants Buprenorphine transdermal system (patch)5mg, 10mg \& 20mg worn for 7 days	Co-codamol Tablets n=58 Participants combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Average Daily Pain Scores - BS11 Pain Scores.	3 Box Scale 11 boxes Standard Deviation 1.31	3 Box Scale 11 boxes Standard Deviation 1.1

Adverse Events

Buprenorphine Transdermal System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Co-codamol Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paul Schofield, Medical Director

Napp Pharmaceutical Ltd

Phone: 01223424444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place