Chronic PainPhase 3NCT00531427

Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

A Phase 3 study testing Buprenorphine in people with Chronic Pain and Osteoarthritis of the Knee, run by Purdue Pharma LP at 87 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

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Pain, Osteoarthritis of the Knee
What is being tested?: Buprenorphine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 567 participants
Where: 87 sitesUnited States
Study dates: Sep 2007to Nov 2009
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
clinical diagnosis of OA of the knee 1 year or longer,
subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,
subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Who cannot join

subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Other protocol-specific inclusion/exclusion criteria may apply.

Trial locations and contacts

87 sites in 1 country.

City, postcode or hospital

87 sites in 1 country

United States87 sites

Research Facility
Anaheim, California, 92801
Research Facility
Atlanta, Georgia, 30342
Research Facility
Augusta, Georgia, 30901
Research Facility
Austin, Texas, 78756
Stat-Lab I, Inc.
Baton Rouge, Louisiana, 70808
Research Facility
Bay City, Michigan, 48706
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211
Premier Internal Medicine
Biloxi, Mississippi, 39531
AMR Research Associates
Bogart, Georgia, 30622-6821
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
Coastal Pain Management
Bradenton, Florida, 34209
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017
Research Facility
Brockton, Massachusetts, 02301
Research Facility
Canton, Ohio, 44718
Radiant Research, Phoenix Southeast
Chandler, Arizona, 85225
Catalina Research Institute
Chino, California, 91710
Research Facility
Cincinnati, Ohio, 45242
Clinical Research of West Florida
Clearwater, Florida, 33765
Research Facility
Clearwater, Florida, 33765
Research Facility
Colleyville, Texas, 76034
Research Facility
Columbus, Ohio, 43213
Research Facility
Columbus, Ohio, 43235
New England Center for Clinical Research
Cranston, Rhode Island, 02920
Research Facility
Cranston, Rhode Island, 02920
Research Facility
Dallas, Texas, 75230
Research Facility
Dawsonville, Georgia, 30534
Digestive Endoscopy Center
Dayton, Ohio, 45415
Research Facility
Dayton, Ohio, 45432
Research Facility
Decatur, Georgia, 30033
Research Facility
Downey, California, 90241
Research Facility
Duncansville, Pennsylvania, 16635
Research Facility
Eugene, Oregon, 97404
Research Facility
Florissant, Missouri, 63031
Research Facility
Foothill Ranch, California, 92610
Research Facility
Frederick, Maryland, 21702
Greenville Pharmaceutical Research
Greenville, South Carolina, 29415
East Coast Clinical Research
Haverhill, Massachusetts, 01830-6141
Research Facility
Henderson, Nevada, 89014
Research Facility
Honolulu, Hawaii, 96814-4526
Rehabilitation Association of IN
Indianapolis, Indiana, 46250
Arthritis Clinic, PLLC
Jackson, Tennessee, 38305
Research Facility
Jupiter, Florida, 33458-7200
Research Facility
Laguna Hills, California, 92653
Oyster Point Family Health Ctr
Lancaster, Pennsylvania, 17601
Research Facility
Largo, Florida, 33765
Research Facility
Littleton, Colorado, 80128
Research Facility
Marietta, Georgia, 30066
Research Facility
Mechanicsburg, Pennsylvania, 17055
Research Facility
Medford, Oregon, 97504-8311
Pharmax Research Clinic
Miami, Florida, 33126
Research Facility
Miami, Florida, 33135
Research Facility
Middleburg Heights, Ohio, 44130
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Research Facility
Morgantown, North Carolina, 28655
Research Facility
Mount Gilead, Ohio, 43338
Research Facility
Nederland, Texas, 77627
Research Facility
New Iberia, Louisiana, 70563
Research Facility
New Orleans, Louisiana, 70114
Research Facility
New York, New York, 10004
Research Facility
New York, New York, 10022
NDC Medical Center
Norfolk, Virginia, 23502
Research Facility
Oklahoma City, Oklahoma, 73109
Research Facility
Orlando, Florida, 32806
Research Facility
Overland Park, Kansas, 66211
Arizona Research Center, Inc.
Phoenix, Arizona, 85023
Research Facility
Phoenix, Arizona, 85029
Research Facility
Phoenix, Arizona, 85032
Research Facility
Plantation, Florida, 33324
Research Facility
Royal Palm Hammock, Florida, 33411
Research Facility
Sacramento, California, 95831
Research Facility
Salt Lake City, Utah, 84102
Research Facility
San Antonio, Texas, 78205-1116
Research Facility
San Antonio, Texas, 78229
Research Facility
Springfield, Massachusetts, 01103
Research Facility
St Louis, Missouri, 63117
Sports Med Consultants PC
St Louis, Missouri, 63141
Research Facility
Stamford, Connecticut, 06905
Research Facility
Sugarland, Texas, 77479
Pacific Northwest Primary Care
Tacoma, Washington, 98405
Clinical Research of West Flor
Tampa, Florida, 33603
Research Facility
Tampa, Florida, 33613
Research Facility
Toledo, Ohio, 43623
Research Facility
Venice, Florida, 34292
Independence Family Medicine
Virginia Beach, Virginia, 23455
Research Facility
West Palm Beach, Florida, 33409
Research Facility
West Reading, Pennsylvania, 19611
Research Facility
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Conditions: Chronic Pain, Osteoarthritis of the Knee
Being tested: Buprenorphine, Placebo
Keywords: Chronic pain,, OA of the knee,, opioid,, transdermal
Medical subject headings: Chronic Pain, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BuprenorphineDrug
transdermal system 10 and 20 applied for 7-day wear
PlaceboDrug
transdermal system (placebo) applied for 7-day wear

Study groups in NCT00531427
Study group	Role	What they receive
1	Experimental	Buprenorphine transdermal system 10 and 20 applied for 7-day wear Receives: Drug: Buprenorphine
2	Placebo comparator	Placebo transdermal system to match BTDS patches, applied for 7-day wear Receives: Drug: Placebo

What is being measured

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

"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.
Measured: 24 hours (week 12)

Secondary outcomes (2)

Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).
Measured: 10 weeks
Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. 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.
Measured: Weeks 4, 8, and 12 of the double-bind phase

Timeline

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

Sep 2007Nov 2009

First posted18 Sep 2007 (estimated)
Study startSep 2007
Primary completionApr 2009
Study completionNov 2009

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 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: 567 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00531427
Sponsor's protocol ID: BUP3025
Status last verified: Sep 2012
First submitted: 17 Sep 2007
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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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: Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee
ClinicalTrials.gov ID: NCT00531427
Acronym / sponsor ID: BUP3025
Conditions: Chronic Pain, Osteoarthritis of the Knee
Keywords: Chronic pain,, OA of the knee,, opioid,, transdermal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 567 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Apr 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 21 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
1	Experimental	Drug: BuprenorphineBuprenorphine transdermal system 10 and 20 applied for 7-day wear
2	Placebo comparator	Drug: PlaceboPlacebo transdermal system to match BTDS patches, applied for 7-day wear

Who may qualify

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

Key inclusion criteria (4 listed)

subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
clinical diagnosis of OA of the knee 1 year or longer,
subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,
subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Key exclusion criteria (4 listed)

subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Other protocol-specific inclusion/exclusion 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
Buprenorphinetransdermal system 10 and 20 applied for 7-day wear	Drug	1
Placebotransdermal system (placebo) applied for 7-day wear	Drug	2

Primary outcome

"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
Time frame: 24 hours (week 12)
"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.

2 secondary outcomes

Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
Time frame: 10 weeks
Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
Time frame: Weeks 4, 8, and 12 of the double-bind phase

Results and safety

Results posted to the registry on 21 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 or 20	282	209
Double-blind Placebo	285	191

Primary outcome: "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.

Time frame: 24 hours (week 12). Mean (Standard Deviation). Unit: units on a scale

Measure	Double-blind BTDS 10 or 20 n = 283	Double-blind Placebo n = 287
Screening (Visit 2)	7.16 (1.340)	7.06 (1.300)
Prerandomization (Visit 3)	2.63 (1.292)	2.74 (1.186)
Double-blind Week 12 (Visit 8)	3.82 (2.644)	4.22 (2.644)

Double-blind BTDS 10 or 20 vs Double-blind Placebo: Mean Difference (Final Values): -0.37 (95% CI -0.80 to 0.05), p = 0.0853, Mixed Models Analysis

Population analysed: The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 resolution or for up to 30 days.. Other adverse events reported at 4.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind BTDS	13 of 282 (4.6%)	108 of 282 (38.3%)	Not reported
Double-blind Placebo	3 of 285 (1.1%)	53 of 285 (18.6%)	Not reported
Open-label Run-in Period	5 of 1,151 (0.4%)	520 of 1,151 (45.2%)	Not reported

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.

87 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 in people with Chronic Pain and Osteoarthritis of the Knee, run by Purdue Pharma LP at 87 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 4 inclusion and 4 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 87 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. 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 21 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?

"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. (time frame: 24 hours (week 12)). 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 NCT00531427.

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.