NCT00315835

Brief Summary

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 postoperative-pain

Timeline
Completed

Started Oct 1996

Geographic Reach
1 country

1 active site

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

October 1, 1996

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1997

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
Last Updated

April 19, 2006

Status Verified

April 1, 2006

First QC Date

April 17, 2006

Last Update Submit

April 17, 2006

Conditions

Postoperative Pain

Keywords

postoperative painopioidtransdermal

Outcome Measures

Primary Outcomes (9)

  • clinical laboratory tests

  • vital signs

  • physical examinations

  • electrocardiograms

  • elicited opioid side effects

  • pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)

  • adverse events

  • application site skin observations

  • plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination

Secondary Outcomes (4)

  • pain intensity

  • acceptability of therapy

  • quality of sleep

  • rescue dose usage

Interventions

Buprenorphine transdermal delivery systemDRUG

Eligibility Criteria

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

You may qualify if:

  • underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively.
  • in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery.

You may not qualify if:

  • receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents.
  • have significant concurrent pulmonary conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Place Therapeutic Center

Plantation, Florida, 33324, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 19, 2006

Study Start

October 1, 1996

Study Completion

November 1, 1997

Last Updated

April 19, 2006

Record last verified: 2006-04

Locations

US(1)