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

This study has been completed.

Sponsor:

Information provided by:

Napp Pharmaceuticals Limited

ClinicalTrials.gov Identifier:

NCT00324038

First received: May 9, 2006

Last updated: June 13, 2011

Last verified: June 2011

History of Changes

Results First Received: July 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Osteoarthritis
Interventions:	Drug: Buprenorphine Drug: Codeine paracetamol

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Primary care. March 2006 to Aug 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for patient eligibility

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Buprenorphine Transdermal System	Co-codamol Tablets
STARTED	110	109
COMPLETED	61	58
NOT COMPLETED	49	51
Adverse Event	38	23
Lack of Efficacy	5	13
Lost to Follow-up	0	2
Unknown	6	13

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	Buprenorphine Transdermal System	Co-codamol Tablets	Total
Number of Participants [units: participants]	110	109	219
Age ^[1] [units: particpants]
<=18 years	0	0	0
Between 18 and 65 years	20	23	43
>=65 years	90	86	176
Gender [units: participants]
Female	75	74	149
Male	35	35	70

[1]	Subjects over 60 years of age were recruited into the study. Initially study started with recruitment age of 65 but this was lowered by protocol amendment to 60 years of age.

Outcome Measures

1. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	Serious and non serious adverse events were collected/assessed but not serious adverse events

Frequency Threshold

Threshold above which other adverse events are reported	0

Reporting Groups

	Description
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

Other Adverse Events

	Buprenorphine Transdermal System	Co-codamol Tablets
Total, other (not including serious) adverse events
# participants affected / at risk	0/0	0/0

Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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