OsteoarthritisPhase 3NCT00312572

Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

A Phase 3 study testing Buprenorphine transdermal patch in people with Osteoarthritis, run by Purdue Pharma LP at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Osteoarthritis
What is being tested?: Buprenorphine transdermal patch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 36 sitesUnited States
Study dates: Jun 2003to Jul 2004
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 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Who cannot join

currently have condition requiring a stable regimen of acetaminophen (APAP).
a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
Other protocol-specific exclusion/inclusion criteria may apply.

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
CEDRA Clinical Research,
Austin, Texas, 78759
Northeast Pain Research Center
Barrington, New Hampshire, 03825
Lovelace Scientific Resources
Beverly Hills, California, 90211
Southern Drug Research
Birmingham, Alabama, 35007
Intermountain Orthopaedics
Boise, Idaho, 83702
Southbay Pharma Research
Buena Park, California, 90620
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210
Community Medical Providers
Clovis, California, 93611
Renaissance Clinical Research & Hypertension Clinic
Dallas, Texas, 75235
Dayton Primary and Urgent Care
Dayton, Ohio, 45402
Kaiser Permanente
Escondido, California, 92025
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, 71913
Spine Care Southwest.
Houston, Texas, 77074
Westside Family Medical Center
Kalamazoo, Michigan, 49009
University of Kansas Medical Center
Kansas City, Kansas, 66160
PCM Medical Services
Lansing, Michigan, 48917
Bluegrass Orthopaedics
Lexington, Kentucky, 40509
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
The Medford Medical Clinic
Medford, Oregon, 97504
Lifespan Research Foundation, Inc.
Miami, Florida, 33186
Miami Beach Anesthesiology Associates
Miami Beach, Florida, 33140
Monroe Medical Foundation
Monroe, Wisconsin, 53566
Neuro Science and Spine Assoc.
Naples, Florida, 34102
Dolby Providers, Inc.
New Orleans, Louisiana, 70128
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, 29118
Redpoint Research
Phoenix, Arizona, 85029
Private Practice
Pine Bluff, Arkansas, 71603
KRK Medical Research
Richardson, Texas, 75080
Univ. of Southern California
Santa Monica, California, 90404
HealthCare Research LLC
St Louis, Missouri, 63141
West Broward Rheumatology Association, Inc.
Tamarac, Florida, 33321
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Tucson Orthopedic Institute
Tucson, Arizona, 85712
Arthritis Center of CT
Waterbury, Connecticut, 06708
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610

Other trials in United States

About this study

Official title: A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain

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: Osteoarthritis
Being tested: Buprenorphine transdermal patch
Keywords: Osteoarthritis, opioid, transdermal
Medical subject headings: Osteoarthritis

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 applied for 7-day wear.

Study groups in NCT00312572
Study group	Role	What they receive
BTDS10/20	Experimental	Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4. Receives: Drug: Buprenorphine transdermal patch
BTDS 20	Experimental	Initial doses (Level 1) of BTDS 20. Receives: Drug: Buprenorphine transdermal patch

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Jul 2004

First posted10 Apr 2006 (estimated)
Study startJun 2003
Primary completionJul 2004
Study completionJul 2004

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies 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: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00312572
Sponsor's protocol ID: BUP3018
Status last verified: Aug 2012
First submitted: 7 Apr 2006
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.
PubMed 22409388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
ClinicalTrials.gov ID: NCT00312572
Acronym / sponsor ID: BUP3018
Conditions: Osteoarthritis
Keywords: Osteoarthritis, opioid, transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jun 2003
Primary completion: Jul 2004 (actual)
Study completion: Jul 2004 (actual)
First posted: 10 Apr 2006 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BTDS10/20	Experimental	Drug: Buprenorphine transdermal patchInitial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.
BTDS 20	Experimental	Drug: Buprenorphine transdermal patchInitial doses (Level 1) of BTDS 20.

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Key exclusion criteria (3 listed)

currently have condition requiring a stable regimen of acetaminophen (APAP).
a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
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 applied for 7-day wear.	Drug	BTDS 20, BTDS10/20

Primary outcome

The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
Time frame: 14 days
The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).

Results and safety

Results posted to the registry on 23 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Double-blind BTDS 10/20	101	85
Double-blind BTDS 20	103	82

Primary outcome: The Percentage of Subjects Who Completed the 14-day Double-blind Phase.

Time frame: 14 days. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Double-blind BTDS 10/20 n = 98	Double-blind BTDS 20 n = 100	Combined Total n = 198
15 - 22.5 mg HCD (Stratum 1)	88 (79.9 to 95.1)	83 (74.7 to 91.9)	85 (79.7 to 91.2)
more than 22.5 - 30 mg HCD (Stratum 2)	85 (70.8 to 98.5)	79 (63.4 to 93.8)	82 (71.1 to 91.8)
Overall	87 (80.0 to 93.5)	82 (74.5 to 89.5)	84 (79.3 to 89.4)

Population analysed: Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization.

Adverse events

Time frame: Adverse events (AEs) that occurred after the signing of the informed consent up to end of study and followed until resolution or 30 days after the last dose of study drug, or discontinuation; serious AEs were followed until the AE stabilized. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind BTDS 10/20	2 of 101 (2%)	31 of 101 (30.7%)	Not reported
Double-blind BTDS 20	3 of 103 (2.9%)	47 of 103 (45.6%)	Not reported
Open-label Run-in Period - Vicodin	0 of 266 (0%)	15 of 266 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22409388Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.

Related trials for Osteoarthritis

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Active, not recruiting
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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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.

36 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 Osteoarthritis, run by Purdue Pharma LP at 36 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 1 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 3 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 36 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?

The Percentage of Subjects Who Completed the 14-day Double-blind Phase. (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00312572, which also lists 1 linked publication.

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 3 Sep 2012.