NCT01151098

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2001

Shorter than P25 for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 23, 2010

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

June 24, 2010

Results QC Date

July 29, 2010

Last Update Submit

September 5, 2012

Conditions

Chronic Nonmalignant Pain

Keywords

Chronic nonmalignant painOpioidTransdermalButrans (BTDS)

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 weeks

Study Arms (1)

BTDS 5, 10 or 20

EXPERIMENTAL

Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

Interventions

Buprenorphine transdermal patchDRUG

Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear

Also known as: Butrans™
BTDS 5, 10 or 20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Arizona Research Center Inc.

Phoenix, Arizona, 85023, United States

Location

Clinical Research Consultants Inc

Trumbull, Connecticut, 06611, United States

Location

Tampa Bay Medical Research Inc

Clearwater, Florida, 33761, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

University Clinical Research Deland

DeLand, Florida, 32720, United States

Location

University Clinical Research Inc,

Pembroke Pines, Florida, 33024, United States

Location

Gold Coast Research, LLC

Plantation, Florida, 33324, United States

Location

Gold Coast Research LLC

Tamarac, Florida, 33321, United States

Location

Family Medicine Associates

Evansville, Indiana, 47712, United States

Location

Pain Management & Rehabilitation

Terre Haute, Indiana, 47807, United States

Location

Southeastern Center for Headache and Pain

Crestview Heights, Kentucky, 41017, United States

Location

Westside Family Medical Center PC

Kalamazoo, Michigan, 49009, United States

Location

The Arthritis Clinic

Charlotte, North Carolina, 28211, United States

Location

Cornerstone Research Care

High Point, North Carolina, 27262, United States

Location

ALL-TRIALS Clinical Research LLC

Winston-Salem, North Carolina, 27103, United States

Location

Summit Research Solutions

Memphis, Tennessee, 38119, United States

Location

Radiant Research - Austin

Austin, Texas, 78758, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Clinical Research Management

New Berlin, Wisconsin, 53151, United States

Location

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Clinical Leader, Executive Medical Director
Organization
Purdue Pharma L.P.
800-733-1333 OR 800-745-7445

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 25, 2010

Study Start

April 1, 2001

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

September 10, 2012

Results First Posted

September 23, 2010

Record last verified: 2012-09

Locations

US(19)