Trial Outcomes & Findings for Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain (NCT NCT01358526)
NCT ID: NCT01358526
Last Updated: 2015-11-11
Results Overview
The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1095 participants
Primary outcome timeframe
24 hours (Week 12)
Results posted on
2015-11-11
Participant Flow
First subject first visit: 25-May-2011; Last subject last visit: 15-Oct-2012. The study was conducted at 132 medical/research sites in the United States.
Opioid-experienced subjects with moderate to severe pain due to chronic low back pain, who required around-the-clock opioid therapy.
Participant milestones
| Measure |
Open-label Titration OXN
The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
|
OXN Group
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|---|
|
Open-label Titration Period
STARTED
|
1095
|
0
|
0
|
|
Open-label Titration Period
COMPLETED
|
601
|
0
|
0
|
|
Open-label Titration Period
NOT COMPLETED
|
494
|
0
|
0
|
|
Double-blind Phase
STARTED
|
0
|
298
|
302
|
|
Double-blind Phase
COMPLETED
|
0
|
218
|
181
|
|
Double-blind Phase
NOT COMPLETED
|
0
|
80
|
121
|
Reasons for withdrawal
| Measure |
Open-label Titration OXN
The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
|
OXN Group
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|---|
|
Open-label Titration Period
Adverse Event
|
95
|
0
|
0
|
|
Open-label Titration Period
Withdrawal by Subject
|
65
|
0
|
0
|
|
Open-label Titration Period
Lost to Follow-up
|
25
|
0
|
0
|
|
Open-label Titration Period
Lack of Efficacy
|
107
|
0
|
0
|
|
Open-label Titration Period
Confirmed or suspected diversion
|
16
|
0
|
0
|
|
Open-label Titration Period
Administrative
|
8
|
0
|
0
|
|
Open-label Titration Period
Did not qualify
|
178
|
0
|
0
|
|
Double-blind Phase
Adverse Event
|
0
|
24
|
23
|
|
Double-blind Phase
Withdrawal by Subject
|
0
|
10
|
8
|
|
Double-blind Phase
Lost to Follow-up
|
0
|
4
|
1
|
|
Double-blind Phase
Lack of Efficacy
|
0
|
31
|
73
|
|
Double-blind Phase
Confirmed or suspected diversion
|
0
|
5
|
6
|
|
Double-blind Phase
Administrative
|
0
|
6
|
10
|
Baseline Characteristics
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
OXN Group
n=298 Participants
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
n=302 Participants
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 10.97 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
229 participants
n=5 Participants
|
233 participants
n=7 Participants
|
462 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
53 participants
n=5 Participants
|
61 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours (Week 12)Population: The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.
Outcome measures
| Measure |
OXN Group
n=298 Participants
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
n=302 Participants
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|
|
The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
|
3.86 units on a scale (0 - 10)
Standard Error 0.116
|
4.32 units on a scale (0 - 10)
Standard Error 0.115
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 12Population: The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.
Outcome measures
| Measure |
OXN Group
n=298 Participants
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
n=302 Participants
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|
|
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
Week 4
|
32.5 units on a scale
Interval 29.4 to 35.7
|
38.0 units on a scale
Interval 34.8 to 41.3
|
|
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
Week 8
|
30.8 units on a scale
Interval 27.8 to 33.9
|
36.8 units on a scale
Interval 33.6 to 39.9
|
|
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
Week 12
|
31.1 units on a scale
Interval 28.1 to 34.2
|
36.4 units on a scale
Interval 33.2 to 39.7
|
SECONDARY outcome
Timeframe: Week 12Population: The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test.
Outcome measures
| Measure |
OXN Group
n=298 Participants
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
n=302 Participants
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
|
153 participants (responders)
|
109 participants (responders)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.
Outcome measures
| Measure |
OXN Group
n=298 Participants
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
n=302 Participants
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|
|
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
|
164 participants (responders)
|
124 participants (responders)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug
A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.
Outcome measures
| Measure |
OXN Group
n=298 Participants
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Placebo Group
n=302 Participants
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
|---|---|---|
|
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
|
109 participants (responders)
|
75 participants (responders)
|
Adverse Events
Open-label Titration OXN
Serious events: 11 serious events
Other events: 79 other events
Deaths: 0 deaths
Double-blind Placebo
Serious events: 12 serious events
Other events: 34 other events
Deaths: 0 deaths
Double-blind OXN
Serious events: 19 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Titration OXN
n=1095 participants at risk
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Double-blind Placebo
n=302 participants at risk
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
Double-blind OXN
n=298 participants at risk
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.66%
2/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Nausea
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Gangrene
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Drug screen positive
|
0.46%
5/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
3.0%
9/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
1/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.33%
1/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.34%
1/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Psychiatric disorders
Drug abuse
|
0.27%
3/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Social circumstances
Substance abuse
|
0.00%
0/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.66%
2/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
Other adverse events
| Measure |
Open-label Titration OXN
n=1095 participants at risk
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
Double-blind Placebo
n=302 participants at risk
Placebo tablets to match OXN
Placebo: Placebo tablets to match OXN taken orally every 12 hours
|
Double-blind OXN
n=298 participants at risk
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.2%
79/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
4.6%
14/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
8.4%
25/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Drug screen positive
|
2.1%
23/1095 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
6.6%
20/302 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
6.4%
19/298 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
Additional Information
Clinical Leader
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