Trial Outcomes & Findings for Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain (NCT NCT00313014)

Last Updated: 2012-09-03

Results Overview

Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

660 participants

Primary outcome timeframe

Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

Results posted on

2012-09-03

Participant Flow

The study began with first patient first visit (FPFV) on 25-Feb-2004 to last patient last visit (LPLV) on 23-Sep-2005, at 75 medical/research sites in the United States.

Prerandomization: screening period \[Prospective assessment: subjects were assessed to ensure compliance with all inclusion/exclusion criteria\]. Opioid taper segment: assessed the severity of the subject's low back pain upon analgesic medication discontinuation. Open-label run-in period: identified subjects whose pain was controlled with BTDS 20.

Participant milestones

Participant milestones
Measure	Double-blind BTDS 5 Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Overall Study STARTED	221	219	220
Overall Study COMPLETED	128	146	159
Overall Study NOT COMPLETED	93	73	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-blind BTDS 5 Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Overall Study Withdrawal by Subject	11	7	5
Overall Study Adverse Event	14	29	16
Overall Study Lost to Follow-up	7	6	10
Overall Study Administrative	9	6	14
Overall Study Lack of Efficacy	52	25	16

Baseline Characteristics

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-blind BTDS 5 n=221 Participants Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 n=219 Participants Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release n=220 Participants Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).	Total n=660 Participants Total of all reporting groups
Age Continuous	50.2 years STANDARD_DEVIATION 12.88 • n=5 Participants	50.4 years STANDARD_DEVIATION 11.93 • n=7 Participants	49.5 years STANDARD_DEVIATION 12.37 • n=5 Participants	50.0 years STANDARD_DEVIATION 12.39 • n=4 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	113 Participants n=7 Participants	100 Participants n=5 Participants	314 Participants n=4 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	106 Participants n=7 Participants	120 Participants n=5 Participants	346 Participants n=4 Participants

PRIMARY outcome

Timeframe: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

Population: Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)

Outcome measures

Outcome measures
Measure	Double-blind BTDS 5 n=221 Participants Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 n=219 Participants Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release n=220 Participants Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. Week 4	3.79 units on a scale Standard Error 0.149	3.40 units on a scale Standard Error 0.128	3.14 units on a scale Standard Error 0.125
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. Screening	6.36 units on a scale Standard Error 0.075	6.46 units on a scale Standard Error 0.084	6.46 units on a scale Standard Error 0.079
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. Prerandomization	2.84 units on a scale Standard Error 0.075	2.91 units on a scale Standard Error 0.075	2.74 units on a scale Standard Error 0.074
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. Week 8	3.83 units on a scale Standard Error 0.162	3.35 units on a scale Standard Error 0.140	3.24 units on a scale Standard Error 0.145
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. Week 12	4.02 units on a scale Standard Error 0.179	3.35 units on a scale Standard Error 0.139	3.26 units on a scale Standard Error 0.152

SECONDARY outcome

Timeframe: Double-blind phase (84 days)

Population: Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase

Outcome measures

Outcome measures
Measure	Double-blind BTDS 5 n=221 Participants Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 n=219 Participants Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release n=220 Participants Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Mean Daily Number of Supplemental Analgesic Tablets	3.8 tablets Standard Error 0.12	3.3 tablets Standard Error 0.13	3.5 tablets Standard Error .13

SECONDARY outcome

Timeframe: Weeks 4, 8, 12

Population: Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)

Outcome measures

Outcome measures
Measure	Double-blind BTDS 5 n=221 Participants Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 n=219 Participants Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release n=220 Participants Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Oswestry Disability Index (ODI) Score (V 2.0) Week 4	34.80 units on a scale Standard Error 1.066	33.04 units on a scale Standard Error 1.019	30.79 units on a scale Standard Error 1.124
Oswestry Disability Index (ODI) Score (V 2.0) Week 8	35.69 units on a scale Standard Error 1.245	34.27 units on a scale Standard Error 1.094	31.64 units on a scale Standard Error 1.165
Oswestry Disability Index (ODI) Score (V 2.0) Week 12	36.30 units on a scale Standard Error 1.392	33.06 units on a scale Standard Error 1.231	32.96 units on a scale Standard Error 1.243

SECONDARY outcome

Timeframe: Weeks 4, 8, 12 of the double-blind phase

Population: Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath). Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

Outcome measures

Outcome measures
Measure	Double-blind BTDS 5 n=221 Participants Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 n=219 Participants Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release n=220 Participants Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. Week 8	42.28 units on a scale Standard Error 2.264	35.69 units on a scale Standard Error 1.721	39.17 units on a scale Standard Error 1.924
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. Week 4	40.67 units on a scale Standard Error 2.025	34.65 units on a scale Standard Error 1.607	38.10 units on a scale Standard Error 1.788
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. Week 12	40.85 units on a scale Standard Error 2.376	33.65 units on a scale Standard Error 1.941	41.60 units on a scale Standard Error 2.205

Adverse Events

Double-blind BTDS 5

Serious events: 6 serious events

Other events: 54 other events

Deaths: 0 deaths

Double-blind BTDS 20

Serious events: 7 serious events

Other events: 118 other events

Deaths: 0 deaths

Double-blind Oxycodone Immediate-Release

Serious events: 9 serious events

Other events: 93 other events

Deaths: 0 deaths

Open-label Run-in Period, BTDS 10/20

Serious events: 10 serious events

Other events: 389 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double-blind BTDS 5 n=221 participants at risk Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	Double-blind BTDS 20 n=219 participants at risk Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	Double-blind Oxycodone Immediate-Release n=220 participants at risk Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	Open-label Run-in Period, BTDS 10/20 n=1160 participants at risk Open-label BTDS 10 or 20 mcg/h applied for 7-day wear
Gastrointestinal disorders Nausea	8.1% 18/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	12.3% 27/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	8.2% 18/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	15.0% 174/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Gastrointestinal disorders Constipation	3.2% 7/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	6.4% 14/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	6.4% 14/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.0% 46/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Gastrointestinal disorders Vomiting NOS	2.3% 5/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	5.0% 11/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.1% 9/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	5.2% 60/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
General disorders Application site erythema	4.5% 10/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	10.0% 22/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	8.6% 19/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	3.3% 38/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
General disorders Application site pruritus	5.4% 12/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	13.2% 29/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	9.1% 20/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	8.8% 102/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
General disorders Application site rash	7.7% 17/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	9.1% 20/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	5.9% 13/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	3.3% 38/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Infections and infestations Upper respiratory tract infection NOS	1.4% 3/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	1.8% 4/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.5% 10/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.34% 4/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 5/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.6% 10/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	1.8% 4/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.69% 8/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Nervous system disorders Headache	5.4% 12/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	11.4% 25/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	9.5% 21/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	10.7% 124/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Nervous system disorders Somnolence	1.8% 4/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.6% 10/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	5.0% 11/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	5.8% 67/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Nervous system disorders Dizziness	2.3% 5/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.6% 10/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	3.6% 8/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	5.3% 62/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	2.3% 5/221 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	4.6% 10/219 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	3.2% 7/220 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.	1.1% 13/1160 • Adverse events occurring after the signing of the informed consent up to end of study and 7 days after, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized. AEs were learned of by spontaneous reports, subject interview, and daily diary.

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