Chronic Non-malignant PainPhase 3NCT00312195
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
A Phase 3 study testing Buprenorphine transdermal patch in people with Chronic Non-malignant Pain, run by Purdue Pharma LP at 42 sites in 2 countries.
Trial summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-malignant Pain
- What is being tested?
- Buprenorphine transdermal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 42 sitesin 2 countries
- Study dates
- Mar 2001to Jul 2001
- 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
- At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
- Good, very good or excellent pain control on current opioid therapy.
- Willing and able to use a telephone interactive voice response service.
Who cannot join
- Currently receiving daily morphine or oxycodone monotherapy.
- Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States21 sites
Radiant Research
Austin, Texas, 78758
Private Practice
Chardon, Ohio, 44024
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, 32702
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
Hawthorne and York
Phoenix, Arizona, 85008
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 and Rehabilitation
Terre Haute, Indiana, 47802
Clinical Research Consultants Inc
Trumbull, Connecticut, 06611
ALL-TRIALS Clinical Research LLC
Winston-Salem, North Carolina, 27103
United Kingdom21 sites
Ashvale Health Centre
Aldershot, Hants, GU12 5BA
Springhill Surgery
Bangor, Co Down, BT19 1PP
Little Common Surgery
Bexhill-on-Sea, E Sussex, TN39 4SP
Old Town Surgery
Bexhill-on-Sea, E Sussex, TN40 2HG
The Ridge Medical Practice, Great Horton
Bradford, West Yorkshire, BD7 3EE
The Academy Medical Practice
Coatbridge, Lanarkshire, L5 3AP
Gables Medical Section
Coventry, Warwickshire, CV6 4DD
The Burns Practice
Doncaster, S Yorkshire, DN1 2EG
Townhead Health Centre
Glasgow, Glasgow, G31 2ES
Castlemilk Health Centre
Glasgow, Glasgow, G45 9AW
Leslie Surgery
Glenrothes, Fife, KY6 3LQ
Roebuck House Surgery
Hastings, E Sussex, TN34 3EY
Valleyfield Health Centre
High Valleyfield, Fife, KY12 8SJ
Houston Surgery
Houston, Renfrewshire, PA6 7AR
Bennett Road Surgery
Keresley End, Coventry, CV7 8LA
Antrim Coast Fundholding Group
Lame, Co Antrim, BT40 1XH
Garden Street Surgery
Magherafelt, Co Derry, BT45 5DD
Whiteabbey Health Centre
Newtownabbey, Belfast, BT37 9QN
Portglenone Health Centre
Portglenone, CO Antrim, BT44 8AD
Grosvenor Medical Centre
Royal Tunbridge Wells, W Sussex, TN1 2EP
Sanbury Health Centre Group Practice
Sunbury-on-Thames, Middx, TW16 6RH
About this study
Official title: An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Read the detailed description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
- Conditions
- Chronic Non-malignant Pain
- Being tested
- Buprenorphine transdermal patch, Placebo to match BTDS
- Keywords
- Chronic pain, opioid, transdermal, Butrans™ [BTDS]
- Medical subject headings
- Chronic Pain
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.
Placebo to match BTDSDrug
Placebo to match buprenorphine transdermal patch 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 |
| Placebo to match BTDS | Placebo comparator | Placebo to match buprenorphine transdermal patch Receives: Drug: Placebo to match BTDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Ineffective treatment was defined as:
- Subject took >1 gram of acetaminophen in a 24-hour period, or
- Subject required a change in transdermal patch (TDS) dose, or
- Subject had difficulty in keeping the TDS on, or
- Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).
Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
Measured: Double-blind phase (14 days)
Secondary outcomes (3)
Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
The time of ineffective treatment was calculated as the earliest of the following:
- The date the subject first took >1 gram of acetaminophen,
- The visit date when ineffective treatment was first determined, or
- The date the last patch was removed.
Measured: 14 days
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
Measured: 14 days
The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startMar 2001
- Primary completionJul 2001
- Study completionJul 2001
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 Non-malignant 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Napp Pharmaceuticals Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312195
- Sponsor's protocol ID
- BUP3201
- Status last verified
- Sep 2012
- First submitted
- 5 Apr 2006
- 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 Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes
- ClinicalTrials.gov ID
- NCT00312195
- Acronym / sponsor ID
- BUP3201
- Conditions
- Chronic Non-malignant Pain
- Keywords
- Chronic pain, opioid, transdermal, Butrans™ [BTDS]
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Collaborators
- Napp Pharmaceuticals Limited
- Study start
- Mar 2001
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Posted 15 Oct 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 is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Detailed description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTDS (5, 10 or 20) | Experimental | Drug: Buprenorphine transdermal patchBuprenorphine transdermal patch |
| Placebo to match BTDS | Placebo comparator | Drug: Placebo to match BTDSPlacebo to match buprenorphine 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)
- At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
- Good, very good or excellent pain control on current opioid therapy.
- Willing and able to use a telephone interactive voice response service.
Key exclusion criteria (3 listed)
- Currently receiving daily morphine or oxycodone monotherapy.
- Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
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) |
| Placebo to match BTDSPlacebo to match buprenorphine transdermal patch applied for 7-day wear. | Drug | Placebo to match BTDS |
Primary outcome
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Time frame: Double-blind phase (14 days)
Ineffective treatment was defined as: * Subject took >1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
3 secondary outcomes
Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
Time frame: 14 days
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Time frame: 14 days
The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
Time frame: 14 days
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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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.
42 sites in 2 countries: 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 Non-malignant Pain, run by Purdue Pharma LP at 42 sites in 2 countries.
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 3 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 42 sites in United States, United Kingdom. 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. Some participants in this study may receive a placebo. 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 15 Oct 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?
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. (time frame: Double-blind phase (14 days)). 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.