Trial Outcomes & Findings for Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement (NCT NCT00403234)
NCT ID: NCT00403234
Last Updated: 2012-09-03
Results Overview
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From signed informed consent to 7 days after end of study (approx. 35 days)
Results posted on
2012-09-03
Participant Flow
Study start date: 02-Nov-2006 (first patient first visit) to 20-Apr-2007 (last patient last visit) at 5 medical/research centers in the US. The study was terminated early due to reasons unrelated to efficacy or safety.
Enrolled: N = 14. Following surgery and recovery from anesthesia, subjects had to demonstrate moderate to severe pain within 6 hours postsurgery ("Pain Right Now" rating of ≥ 2 on a 4-point scale where 0 = no pain and 3 = severe pain), then their intravenous patient-controlled analgesia morphine device was activated. N = 10 were randomized.
Participant milestones
| Measure |
Placebo
Placebo transdermal patch applied for 7-day wear.
|
BTDS 10
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
|
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
BTDS 30
Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo transdermal patch applied for 7-day wear.
|
BTDS 10
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
|
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
BTDS 30
Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Placebo transdermal patch applied for 7-day wear
|
BTDS 10
n=3 Participants
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
|
BTDS 20
n=3 Participants
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
BTDS 30
n=2 Participants
Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
67 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 7.37 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 4.04 • n=5 Participants
|
59 years
STANDARD_DEVIATION 7.07 • n=4 Participants
|
62.6 years
STANDARD_DEVIATION 6.87 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From signed informed consent to 7 days after end of study (approx. 35 days)Population: The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment.
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo transdermal patch applied for 7-day wear
|
BTDS 10
n=3 Participants
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
|
BTDS 20
n=3 Participants
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
BTDS 30
n=2 Participants
Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Deaths
|
0 participants
0
|
0 participants
0
|
0 participants
0
|
0 participants
0
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
All Other Adverse Events in ≥ 4.5% of subjects
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BTDS 10
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BTDS 20
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BTDS 30
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
Placebo transdermal patch applied for 7-day wear.
|
BTDS 10
n=3 participants at risk
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
|
BTDS 20
n=3 participants at risk
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
BTDS 30
n=2 participants at risk
Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
2/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
66.7%
2/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
66.7%
2/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
General disorders
Chest pain
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
General disorders
Chills
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
100.0%
2/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Investigations
Gamma-Glutamyltransferase increased
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
66.7%
2/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
66.7%
2/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
33.3%
1/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
0.00%
0/3 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
50.0%
1/2 • Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs were learned of through spontaneous reports and subject interview.
|
Additional Information
Clinical Leader, Director of Clinical Research
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