Trial Outcomes & Findings for Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015 (NCT NCT01125917)
NCT ID: NCT01125917
Last Updated: 2012-09-03
Results Overview
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
354 participants
Primary outcome timeframe
52-week extension phase
Results posted on
2012-09-03
Participant Flow
Study dates: 17-Jun-2004 to 23-Sep-2005 at 52 medical/research sites in the United States participated in the extension study.
Subjects who completed all visits of the 12-week double-blind phase on study drug as well as subjects who both discontinued study drug due to lack of therapeutic effect in the double-blind phase and completed all visits of the double-blind phase off study drug were eligible for enrollment in the extension phase.
Participant milestones
| Measure |
Total BTDS 5, 10, 20
Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
|
|---|---|
|
Overall Study
STARTED
|
354
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
339
|
Reasons for withdrawal
| Measure |
Total BTDS 5, 10, 20
Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
|
|---|---|
|
Overall Study
Adverse Event
|
43
|
|
Overall Study
Lost to Follow-up
|
23
|
|
Overall Study
Withdrawal by Subject
|
31
|
|
Overall Study
Administrative
|
223
|
|
Overall Study
Lack of Efficacy
|
19
|
Baseline Characteristics
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Baseline characteristics by cohort
| Measure |
Total BTDS 5, 10, 20
n=354 Participants
Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
|
|---|---|
|
Age Continuous
|
51.2 years
STANDARD_DEVIATION 12.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52-week extension phasePopulation: The Extension Safety Population (N = 354) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Outcome measures
| Measure |
Total BTDS 5, 10, 20
n=354 Participants
Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
|
|---|---|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Death
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Serious adverse events
|
20 participants
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
All other adverse events in ≥ 4.5% of subjects
|
153 participants
|
Adverse Events
Total BTDS 5, 10, 20
Serious events: 20 serious events
Other events: 153 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total BTDS 5, 10, 20
n=354 participants at risk
Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Nausea
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Intractable nausea
|
0.28%
1/354 • Number of events 2 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Intractable vomiting
|
0.28%
1/354 • Number of events 2 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Acute cardiac death
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Angina
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Chest pain
|
0.56%
2/354 • Number of events 2 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Chest pressure
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Hepatobiliary disorders
Acalculous cholecystitis
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Immune system disorders
Allergic reaction
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Infections and infestations
Helicobacter pylori
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Infections and infestations
Hepatitis C
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Implant failure left knee
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Spinal column blood clot secondary to T11-12 laparoscopic cyst removal
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
2/354 • Number of events 2 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Acute mid back pain
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease, right hip
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Worsening of left knee OA
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sigmoid colon cancer
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Dizziness
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Loss of consciousness
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Probable seizure disorder
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Progression of lumbar spinal stenosis
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Acute exacerbation of COPD
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Social circumstances
Cocaine abuse
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Pregnancy, puerperium and perinatal conditions
Placental abruption
|
0.28%
1/354 • 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, discontinuation, or serious AEs occurring up to 30 days following the last study visit were followed until the AE or sequelae resolved.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
Other adverse events
| Measure |
Total BTDS 5, 10, 20
n=354 participants at risk
Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.6%
34/354 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site pruritus
|
10.5%
37/354 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site erythema
|
10.2%
36/354 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site rash
|
9.0%
32/354 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
27/354 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
4.5%
16/354 • Adverse events(AEs) that occurred 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.
AEs were learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Headache
|
15.5%
55/354 • Adverse events(AEs) that occurred 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.
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