Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

NCT00312195 | Completed Phase 3 Results

• 1 other identifier: BUP3201
• Study Type: interventional
• Target: 267
• Locations: 2 countries
• Sites: 42

Brief 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. 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.

Conditions

Chronic Non-malignant Pain

Keywords

Chronic pain; opioid; transdermal; Butrans™ [BTDS]

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  14 days

• The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).

  14 days

Study Arms (2)

BTDS (5, 10 or 20)

EXPERIMENTAL

Buprenorphine transdermal patch

Drug: Buprenorphine transdermal patch

Placebo to match BTDS

PLACEBO COMPARATOR

Placebo to match buprenorphine transdermal patch

Drug: Placebo to match BTDS

Interventions

Buprenorphine transdermal patch DRUG

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

Also known as: Butrans™

BTDS (5, 10 or 20)

Placebo to match BTDS DRUG

Placebo to match buprenorphine transdermal patch applied for 7-day wear.

Placebo to match BTDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead
• Napp Pharmaceuticals Limited: collaborator

Study Sites (42)

Hawthorne and York

Phoenix, Arizona, 85008, United States

Location

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, 32702, 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 and Rehabilitation

Terre Haute, Indiana, 47802, 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

Private Practice

Chardon, Ohio, 44024, United States

Location

Summit Research Solutions

Memphis, Tennessee, 38119, United States

Location

Radiant Research

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

Whiteabbey Health Centre

Newtownabbey, Belfast, BT37 9QN, United Kingdom

Location

Antrim Coast Fundholding Group

Lame, Co Antrim, BT40 1XH, United Kingdom

Location

Portglenone Health Centre

Portglenone, CO Antrim, BT44 8AD, United Kingdom

Location

Garden Street Surgery

Magherafelt, Co Derry, BT45 5DD, United Kingdom

Location

Springhill Surgery

Bangor, Co Down, BT19 1PP, United Kingdom

Location

Bennett Road Surgery

Keresley End, Coventry, CV7 8LA, United Kingdom

Location

Little Common Surgery

Bexhill-on-Sea, E Sussex, TN39 4SP, United Kingdom

Location

Old Town Surgery

Bexhill-on-Sea, E Sussex, TN40 2HG, United Kingdom

Location

Roebuck House Surgery

Hastings, E Sussex, TN34 3EY, United Kingdom

Location

Leslie Surgery

Glenrothes, Fife, KY6 3LQ, United Kingdom

Location

Valleyfield Health Centre

High Valleyfield, Fife, KY12 8SJ, United Kingdom

Location

Townhead Health Centre

Glasgow, Glasgow, G31 2ES, United Kingdom

Location

Castlemilk Health Centre

Glasgow, Glasgow, G45 9AW, United Kingdom

Location

Ashvale Health Centre

Aldershot, Hants, GU12 5BA, United Kingdom

Location

The Academy Medical Practice

Coatbridge, Lanarkshire, L5 3AP, United Kingdom

Location

Sanbury Health Centre Group Practice

Sunbury-on-Thames, Middx, TW16 6RH, United Kingdom

Location

Houston Surgery

Houston, Renfrewshire, PA6 7AR, United Kingdom

Location

The Burns Practice

Doncaster, S Yorkshire, DN1 2EG, United Kingdom

Location

Grosvenor Medical Centre

Royal Tunbridge Wells, W Sussex, TN1 2EP, United Kingdom

Location

Gables Medical Section

Coventry, Warwickshire, CV6 4DD, United Kingdom

Location

The Ridge Medical Practice, Great Horton

Bradford, West Yorkshire, BD7 3EE, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Leader, Executive Medical Director
• Organization: Purdue Pharma L.P.

800-733-1333

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 7, 2006
• Study Start: March 1, 2001
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: September 10, 2012
• Results First Posted: October 15, 2010

Record last verified: 2012-09

Locations

GB (21); US (21)