Trial Outcomes & Findings for Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase (NCT NCT01135524)

NCT ID: NCT01135524

Last Updated: 2012-09-10

Results Overview

Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 196 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2012-09-10

Participant Flow

02-Apr-2004 (first subject first visit, core study) to 05-Aug-2005 (last subject last visit, extension phase), in 82 sites in the US; 59 sites randomized at least 1 subject.

Subjects with moderate to severe osteoarthritis (OA) pain who required opioid analgesia; completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase and completed all visits of the double-blind phase off study drug were eligible for the extension phase.

Participant milestones

Measure	Extension Phase Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
Overall Study STARTED	196
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	196

Reasons for withdrawal

Measure	Extension Phase Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
Overall Study Withdrawal by Subject	14
Overall Study Adverse Event	20
Overall Study Lost to Follow-up	3
Overall Study Administrative	151
Overall Study Lack of Efficacy	8

Baseline Characteristics

Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Baseline characteristics by cohort

Measure	Extension Phase n=196 Participants Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
Age Continuous	58.4 years STANDARD_DEVIATION 9.83 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: The Extension Safety Population (N = 196) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.

Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

Outcome measures

Measure	Extension Phase n=196 Participants Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability Deaths	1 participants
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability Serious Adverse Events	14 participants
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability Other Adverse Events in ≥ 4.5% of subjects	93 participants

Adverse Events

Extension Phase

Serious events: 14 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Measure	Extension Phase n=196 participants at risk Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
Musculoskeletal and connective tissue disorders Aggravated osteoarthritis	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
General disorders Atypical chest pain	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Nervous system disorders Cerebrovascular accident	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
General disorders Chest pain	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Vascular disorders Gangrene right foot	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Gastrointestinal disorders Gastroenteritis	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Musculoskeletal and connective tissue disorders Herniated lumbar disc	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Respiratory, thoracic and mediastinal disorders Left lung pneumothorax	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Cardiac disorders Mild myocardial infarction	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Cardiac disorders Myocardial infarction	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Gastrointestinal disorders Rectal polyp	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Cardiac disorders Unstable angina	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Investigations Weight loss	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
General disorders Withdrawal symptoms	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Gastrointestinal disorders Worsening hiatal hernia	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Musculoskeletal and connective tissue disorders Worsening left hip OA	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Nervous system disorders Worsening of lumbar stenosis	0.51% 1/196 • Number of events 1 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.

Other adverse events

Measure	Extension Phase n=196 participants at risk Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
General disorders Application site erythema	5.6% 11/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
General disorders Application site pruritus	11.2% 22/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
General disorders Application site rash	10.2% 20/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Musculoskeletal and connective tissue disorders Arthralgia	9.7% 19/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Gastrointestinal disorders Constipation	4.6% 9/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Nervous system disorders Headache	15.8% 31/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Musculoskeletal and connective tissue disorders Joint swelling	4.6% 9/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Gastrointestinal disorders Nausea	6.1% 12/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
General disorders Pain NOS	5.1% 10/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Musculoskeletal and connective tissue disorders Pain in limb	5.1% 10/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.
Infections and infestations Urinary tract infection NOS	5.1% 10/196 • Extension phase: AEs occurring after the application of the first patch during the extension phase were recorded up to 7 days after the last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved. AEs were obtained through spontaneous reports and subject interview.

Additional Information

Clinical Leader, Medical Director

Purdue Pharma L.P.

Phone: 800-733-1333

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60