PainPhase 3NCT01324570

Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children

A Phase 3 study testing Buprenorphine transdermal system in people with Pain, run by Purdue Pharma LP at 22 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 purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years. Read more about this study

Who is it for?: Ages 7 to 16 years
Conditions the study is for: Pain
What is being tested?: Buprenorphine transdermal system
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 22 sitesUnited States
Study dates: Jul 2011to May 2016
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 7 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female patients, 7 to 16 years of age, inclusive, with malignant and/or nonmalignant moderate to severe pain requiring or anticipated to require continuous, around-the-clock, opioid treatment for at least 2 weeks (based on the investigator's judgment);
Patients must have written informed consent provided by the parent or legal guardian and assent provided by the patient, when appropriate;
Patients on incoming opioids must be taking ≤ 80 mg/day morphine or equivalent if aged 12 to 16 years or ≤ 40 mg/day morphine or equivalent if aged 7 to 11 years prior to the screening visit;
Patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity. Patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale.

Who cannot join

Patients who are allergic to buprenorphine or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]) or who have allergies or other contraindications to transdermal delivery systems or patch adhesives;
Patients with a dermatological disorder, including burn and skin graft sites, at any relevant patch application site that would preclude proper placement and/or rotation of BTDS patches;
Patients with evidence of impaired renal function;
Patients with hepatic impairment;
Patients with history of seizures;
Patients with intracranial pressure;

Show all 12Show fewer

Patients who have a history of sleep apnea within the past year;
Patients who require mechanical ventilation during study treatment period, are cyanotic, or who have unstable respiratory disease;
Patients with clinically significant structural heart disease or a pacemaker;
Patients with clinically unstable cardiac disease;
Patients who receive or anticipate to receive investigational medication/therapy during study drug treatment period.
Other protocol-specific inclusion/exclusion criteria may apply.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Children's Blood and Cancer Center
Austin, Texas, 78723
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612
Vidant Medical Center
Greenville, North Carolina, 27834
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Long Beach Memorial Medical Center
Long Beach, California, 90806
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Health Center
Los Angeles, California, 90095-1752
Kosair Charities Pediatric Clinical Research Unit - University of Louisville
Louisville, Kentucky, 40202
Jackson Memorial Hospital / University of Miami
Miami, Florida, 33136
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
WCMC, Department of Pediatrics - Hematology/Oncology
New York, New York, 10065
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Rhode Island Hospital, Department of Pediatrics
Providence, Rhode Island, 02903
Road Runner Research, Ltd.
San Antonio, Texas, 78258
Willis-Knighton Physician Network
Shreveport, Louisiana, 71118
Stony Brook University Hospital
Stony Brook, New York, 11794
Children's Hospital at Montefiore
The Bronx, New York, 10467
Howard University Hospital
Washington D.C., District of Columbia, 20060
The Center for Clinical Research - Carolina Pain Institute
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain

The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

Read the detailed description

A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.

Conditions: Pain
Being tested: Buprenorphine transdermal system
Keywords: Pain, Opioid, Analgesia, Moderate to severe pain
Medical subject headings: Pain, Agnosia

What participants receive

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

Buprenorphine transdermal systemDrug
Also called Butrans
Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.

Study groups in NCT01324570
Study group	Role	What they receive
Overall BTDS	Experimental	Buprenorphine transdermal system Receives: Drug: Buprenorphine transdermal system

What is being measured

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

The Number of Participants With Adverse Events as a Measure of Safety
Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale [UMSS]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.
Measured: Up to 28 weeks
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.
Measured: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.
Measured: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit

Secondary outcomes (3)

Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive
Pain right now was assessed using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the intensities are scored as 0, 2, 4, 6, 8, or 10. A score of 0=no pain, and 10=very much pain. For screening to week 4, pain right now was assessed at 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline score was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.
The study measured pain right now for weeks 6-24 once a week at approximately 8 PM while on treatment; however, no patients in this age group were treated beyond week 12.
Measured: Up to 24 weeks
Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive
Pain right now was assessed using a 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked as "no pain" and the other marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. Pain right now score was defined as the distance (in mm) from the "no pain" end to the patient's mark; 0=no pain and bigger numbers indicate more pain. For screening to week 4, pain right now was assessed 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.
For weeks 6-24, pain right now was measured once a week at approximately 8 PM.
Measured: Up to 24 weeks
Parent/Caregiver-assessed Global Impression of Change (PGIC)
The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The PGIC score was summarized using the number and percent of patients in each of the 7 possible response categories overall and by age group. PGIC was assessed by the parent/caregiver at the end of treatment visit or early discontinuation visit.
Measured: End of treatment (week 24) or early discontinuation visit

Timeline

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

Jul 2011May 2016

First posted29 Mar 2011 (estimated)
Study startJul 2011
Primary completionMay 2016
Study completionMay 2016

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 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: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01324570
Sponsor's protocol ID: BUP3031
Other IDs: 2010-021954-21
Status last verified: Jun 2017
First submitted: 24 Mar 2011
Last updated: 6 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain
ClinicalTrials.gov ID: NCT01324570
Acronym / sponsor ID: BUP3031
Conditions: Pain
Keywords: Pain, Opioid, Analgesia, Moderate to severe pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 29 Mar 2011 (estimated)
Results: Posted 6 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

Detailed description

A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Overall BTDS	Experimental	Drug: Buprenorphine transdermal systemBuprenorphine transdermal system

Who may qualify

Ages: 7 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male and female patients, 7 to 16 years of age, inclusive, with malignant and/or nonmalignant moderate to severe pain requiring or anticipated to require continuous, around-the-clock, opioid treatment for at least 2 weeks (based on the investigator's judgment);
Patients must have written informed consent provided by the parent or legal guardian and assent provided by the patient, when appropriate;
Patients on incoming opioids must be taking ≤ 80 mg/day morphine or equivalent if aged 12 to 16 years or ≤ 40 mg/day morphine or equivalent if aged 7 to 11 years prior to the screening visit;
Patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity. Patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale.

Key exclusion criteria (12 listed)

Patients who are allergic to buprenorphine or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]) or who have allergies or other contraindications to transdermal delivery systems or patch adhesives;
Patients with a dermatological disorder, including burn and skin graft sites, at any relevant patch application site that would preclude proper placement and/or rotation of BTDS patches;
Patients with evidence of impaired renal function;
Patients with hepatic impairment;
Patients with history of seizures;

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 systemAlso: ButransBuprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.	Drug	Overall BTDS

Primary outcome

The Number of Participants With Adverse Events as a Measure of Safety
Time frame: Up to 28 weeks
Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale [UMSS]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)
Time frame: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.
Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)
Time frame: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit
The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.

3 secondary outcomes

Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive
Time frame: Up to 24 weeks
Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive
Time frame: Up to 24 weeks
Parent/Caregiver-assessed Global Impression of Change (PGIC)
Time frame: End of treatment (week 24) or early discontinuation visit

Results and safety

Results posted to the registry on 6 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
7 to 11 Years	6	2
12 to 16 Years	35	21

Primary outcome: The Number of Participants With Adverse Events as a Measure of Safety

Time frame: Up to 28 weeks. Count of participants. Unit: Participants

Measure	7 to 11 Years n = 6	12 to 16 Years n = 35
Serious adverse events	5	5
All other adverse events in ≥ 5% of patients	6	20

Population analysed: The safety population (N=41) was the group of patients who received at least 1 dose of study drug during the study.

Primary outcome: Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)

Time frame: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit. Mean (95% Confidence Interval). Unit: Liters/hour

Measure	Population PK Analysis Set n = 38
Value	293 (264 to 326)

Population analysed: The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.

Primary outcome: Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)

Time frame: Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit. Mean (95% Confidence Interval). Unit: Liters

Measure	Population PK Analysis Set n = 38
Value	2350 (1950 to 2820)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious treatment-emergent adverse events (TEAEs) were collected from the initiation of treatment with study drug up to 7 days after the last dose of study drug. Serious adverse events (SAEs) were collected from the signing of the informed consent form through 30 days of the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7 to 11 Years	5 of 6 (83.3%)	6 of 6 (100%)	0 of 6
12 to 16 Years	5 of 35 (14.3%)	20 of 35 (57.1%)	0 of 35

Limitations and caveats (from the sponsor): Patient recruitment in the younger age group was difficult and the sample size is smaller than the older age group. This limitation should be a consideration when interpreting the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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.

22 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 system in people with Pain, run by Purdue Pharma LP at 22 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 12 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 6 Jul 2017). 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 Participants With Adverse Events as a Measure of Safety (time frame: Up to 28 weeks). The study lists 3 primary outcomes in all. 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 NCT01324570.

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 6 Jul 2017.