Chronic Nonmalignant PainPhase 3NCT01151098
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
A Phase 3 study testing Buprenorphine transdermal patch in people with Chronic Nonmalignant Pain, run by Purdue Pharma LP at 19 sites in United States.
Trial summary
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Nonmalignant Pain
- What is being tested?
- Buprenorphine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2001to Feb 2002
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Include:
- Subjects of either sex aged 18 years or older.
- Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.
Who cannot join
- Include:
- Subjects currently receiving daily morphine or oxycodone (mono-therapy).
- Subjects who are discontinued from BUP3201 due to adverse events.
- Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.
- Refer to core study for additional inclusion/exclusion information.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Radiant Research - Austin
Austin, Texas, 78758
The Arthritis Clinic
Charlotte, North Carolina, 28211
Tampa Bay Medical Research Inc
Clearwater, Florida, 33761
Clinical Research of South Florida
Coral Gables, Florida, 33134
Southeastern Center for Headache and Pain
Crestview Heights, Kentucky, 41017
University Clinical Research Deland
DeLand, Florida, 32720
Family Medicine Associates
Evansville, Indiana, 47712
Cornerstone Research Care
High Point, North Carolina, 27262
Westside Family Medical Center PC
Kalamazoo, Michigan, 49009
Summit Research Solutions
Memphis, Tennessee, 38119
Clinical Research Management
New Berlin, Wisconsin, 53151
University Clinical Research Inc,
Pembroke Pines, Florida, 33024
Arizona Research Center Inc.
Phoenix, Arizona, 85023
Gold Coast Research, LLC
Plantation, Florida, 33324
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Gold Coast Research LLC
Tamarac, Florida, 33321
Pain Management & Rehabilitation
Terre Haute, Indiana, 47807
Clinical Research Consultants Inc
Trumbull, Connecticut, 06611
ALL-TRIALS Clinical Research LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
Read the detailed description
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.
- Conditions
- Chronic Nonmalignant Pain
- Being tested
- Buprenorphine transdermal patch
- Keywords
- Chronic nonmalignant pain, Opioid, Transdermal, Butrans (BTDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear
| Study group | Role | What they receive |
|---|---|---|
| BTDS 5, 10 or 20 | Experimental | Buprenorphine transdermal patch Receives: Drug: Buprenorphine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startApr 2001
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Nonmalignant PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151098
- Sponsor's protocol ID
- BUP3201S
- Status last verified
- Sep 2012
- First submitted
- 24 Jun 2010
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.
- ClinicalTrials.gov ID
- NCT01151098
- Acronym / sponsor ID
- BUP3201S
- Conditions
- Chronic Nonmalignant Pain
- Keywords
- Chronic nonmalignant pain, Opioid, Transdermal, Butrans (BTDS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 23 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
Detailed description
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTDS 5, 10 or 20 | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of either sex aged 18 years or older.
- Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.
Key exclusion criteria (5 listed)
- Subjects currently receiving daily morphine or oxycodone (mono-therapy).
- Subjects who are discontinued from BUP3201 due to adverse events.
- Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.
- Refer to core study for additional inclusion/exclusion information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine transdermal patchAlso: Butrans™Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear | Drug | BTDS 5, 10 or 20 |
Primary outcome
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Time frame: 28 weeks
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial
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Enrolling by invitation
Collaboratory Treatment Pathway for Chronic Pain Patients.
Chronic Pain, Chronic Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine transdermal patch in people with Chronic Nonmalignant Pain, run by Purdue Pharma LP at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) as a Measure of Safety. (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.