Trial Outcomes & Findings for Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase (NCT NCT01141283)
NCT ID: NCT01141283
Last Updated: 2012-09-03
Results Overview
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
290 participants
Primary outcome timeframe
6 months.
Results posted on
2012-09-03
Participant Flow
28-May-2003 (first patient first visit) to 02-Jul-2004 (last patient last visit of extension phase). This study was conducted at 11 medical/research sites in the U.S.
All subjects meeting the protocol-specified definition of "double blind phase completer" were eligible to participate in the extension phase within 3 days. Completers were defined as those who either developed inadequate analgesia in the double-blind phase or completed all 28 days of the double-blind phase on study drug with adequate analgesia.
Participant milestones
| Measure |
Extension Phase (BTDS 5, 10, or 20)
Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
|
|---|---|
|
Overall Study
STARTED
|
290
|
|
Overall Study
COMPLETED
|
202
|
|
Overall Study
NOT COMPLETED
|
88
|
Reasons for withdrawal
| Measure |
Extension Phase (BTDS 5, 10, or 20)
Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
|
|---|---|
|
Overall Study
Adverse Event
|
56
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Administrative
|
4
|
|
Overall Study
Lack of Efficacy
|
10
|
Baseline Characteristics
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Baseline characteristics by cohort
| Measure |
Extension Phase (BTDS 5, 10, or 20)
n=290 Participants
Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
|
|---|---|
|
Age Continuous
|
60.4 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months.Population: The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during 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 (BTDS 5, 10, or 20)
n=290 Participants
Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
|
|---|---|
|
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Deaths
|
0 participants
0
|
|
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serious Adverse Events
|
6 participants
|
|
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse Events 4.5%
|
202 participants
|
Adverse Events
Extension Phase (BTDS 5, 10, or 20)
Serious events: 6 serious events
Other events: 202 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extension Phase (BTDS 5, 10, or 20)
n=290 participants at risk
Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
|
|---|---|
|
General disorders
Chest pain
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Chest pain atypical
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Infections and infestations
Left foot osteomyelitis
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of osteoarthritis (OA) in the right knee
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Transient ischemic attack
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Dysarthria
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Left lateral intraventricular hemorrhage
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Seizure
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Syncopal episode
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulceration left foot
|
0.34%
1/290 • Number of events 1 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
Other adverse events
| Measure |
Extension Phase (BTDS 5, 10, or 20)
n=290 participants at risk
Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
13.1%
38/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Constipation
|
12.8%
37/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Vomiting NOS
|
5.9%
17/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Application site pruritus
|
12.4%
36/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Application site rash
|
13.4%
39/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Application site erythema
|
13.4%
39/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Application site irritation
|
6.6%
19/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
5.9%
17/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.4%
36/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
35/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
7.6%
22/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Headache
|
22.8%
66/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Somnolence
|
4.8%
14/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.6%
19/290 • Adverse events ongoing at study completion must be followed until resolution or for 30 days after the last dose of study drug, whichever comes first. SAEs must be followed until the event resolves or the event or sequelae stabilize.
Adverse events were obtained through spontaneous reports and subject interview.
|
Additional Information
Clinical Leader, Medical Director
Purdue Pharma LP
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60