Trial Outcomes & Findings for Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee (NCT NCT00313846)

Last Updated: 2012-09-03

Results Overview

Inadequate analgesia: * "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or; * \>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or; * ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

529 participants

Primary outcome timeframe

Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods

Results posted on

2012-09-03

Participant Flow

25-Apr-2003 (first patient first visit) to 01-Jun-2004 (last patient last visit). This study was conducted at 41 medical/research sites in the United States.

529 subjects began the run-in period with buprenorphine transdermal system (BTDS) 5 and their dose was titrated to BTDS 10 or 20 to achieve effective pain control. Subjects meeting criteria for adequate analgesia within 21 days were randomized into the double-blind phase (the number of subjects \[N\] = 328 completed run-in period).

Participant milestones

Participant milestones
Measure	Double-blind Placebo Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.	Double-blind BTDS Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
Overall Study STARTED	162	164
Overall Study COMPLETED	157	153
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-blind Placebo Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.	Double-blind BTDS Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
Overall Study Withdrawal by Subject	2	0
Overall Study Adverse Event	1	8
Overall Study Administrative	2	3

Baseline Characteristics

Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-blind Placebo n=162 Participants Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.	Double-blind BTDS n=164 Participants Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.	Total n=326 Participants Total of all reporting groups
Age Continuous	61.2 years STANDARD_DEVIATION 9.64 • n=5 Participants	60.4 years STANDARD_DEVIATION 9.28 • n=7 Participants	60.8 years STANDARD_DEVIATION 9.45 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	113 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	51 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods

Population: The Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.

Outcome measures

Outcome measures
Measure	Double-blind Placebo n=162 Participants Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.	Double-blind BTDS n=164 Participants Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.	12.3 days Standard Error 0.77	17.2 days Standard Error 0.89

SECONDARY outcome

Timeframe: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.

Population: Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.

The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).

Outcome measures

Outcome measures
Measure	Double-blind Placebo n=162 Participants Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.	Double-blind BTDS n=164 Participants Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site	3.8 units on a scale Standard Error 0.15	3.2 units on a scale Standard Error 0.14

Adverse Events

Double-blind Placebo Patch 5, 10, or 20

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Double-blind BTDS 5, 10, or 20

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Open-label Run-in Period BTDS 5, 10, or 20

Serious events: 6 serious events

Other events: 229 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double-blind Placebo Patch 5, 10, or 20 n=162 participants at risk Reference treatment in the double-blind phase	Double-blind BTDS 5, 10, or 20 n=164 participants at risk Test treatments in the double-blind phase	Open-label Run-in Period BTDS 5, 10, or 20 n=529 participants at risk Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
Cardiac disorders Intermittent complete heart block	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Infections and infestations Pneumonia	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Infections and infestations Left foot cellulitis	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Infections and infestations Acute upper respiratory tract infection	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Investigations Elevated blood pressure	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Transient ischemic attack	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Numbness left side of face	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Cerebrovascular accident	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Tremulousness	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Psychiatric disorders Anxiety	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.19% 1/529 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Vascular disorders Worsening of hypertension	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.00% 0/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.

Other adverse events

Other adverse events
Measure	Double-blind Placebo Patch 5, 10, or 20 n=162 participants at risk Reference treatment in the double-blind phase	Double-blind BTDS 5, 10, or 20 n=164 participants at risk Test treatments in the double-blind phase	Open-label Run-in Period BTDS 5, 10, or 20 n=529 participants at risk Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
Gastrointestinal disorders Nausea	1.9% 3/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	7.3% 12/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	21.4% 113/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Gastrointestinal disorders Constipation	3.7% 6/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	6.1% 10/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	7.8% 41/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Gastrointestinal disorders Vomiting not otherwise specified (NOS)	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	0.61% 1/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	6.8% 36/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
General disorders Application site erythema	3.1% 5/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	5.5% 9/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	1.1% 6/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
General disorders Application site pruritus	2.5% 4/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	4.9% 8/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	5.3% 28/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Headache	9.3% 15/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	4.3% 7/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	12.3% 65/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Dizziness	2.5% 4/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	3.0% 5/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	10.4% 55/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.
Nervous system disorders Somnolence	0.00% 0/162 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	1.2% 2/164 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded through spontaneous reports and subject interview.	7.8% 41/529 • Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, or discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized. Adverse events (AEs) were recorded 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