A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery

June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus ULTRAM® (Tramadol HCl) Versus Placebo in Subjects With Pain Following Oral Surgery

The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While other studies have shown the effectiveness and safety of tramadol/acetaminophen and of tramadol alone in treating pain following oral surgery, a direct comparison of the two treatments within the same study at these dose levels has not be performed. This is a single-center, randomized, double-blind, active- and placebo-controlled, single-dose, parallel-group study of adult patients who undergo oral surgery for removal of two or more impacted third molars. Patients who have at least moderate pain within 5 hours after surgery will be given a single oral dose of 2 capsules of study medication. Patients will be equally assigned to receive a total dose of either tramadol HCl 75 mg/acetaminophen 650 mg or tramadol HCl 100 mg or placebo. Patients will be asked about the intensity of the current pain and pain relief from the starting pain at 30 minutes and at 1, 2, 3, 4, 5 and 6 hours after taking the study medication. Patients will also be given two stopwatches that will be started once medication has been taken. Patients will stop the first stopwatch when they first notice any pain decrease; they will stop the second stopwatch when they notice meaningful pain relief. The primary efficacy endpoints are summary measures of hourly patient reported pain relief (PAR) and pain intensity scores: total PAR (TOTPAR), sum of hourly pain intensity differences (PIDs) from baseline (SPID), and sum of hourly PAR plus hourly PIDs from baseline (SPRID). The study hypothesis is that pain relief with tramadol HCl/acetaminophen (ULTRACET®) is superior to pain relief from tramadol HCl (ULTRAM®) alone after oral surgery and the combination is well tolerated.

2 capsules, total dose either tramadol HCl 75 milligrams/acetaminophen 650 milligrams, tramadol HCl 100 milligrams, or matching placebo taken one time orally; all study medication is over-capsulated to match.

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical procedure involving removal of >= 2 impacted third molars with bone removal required for at least 2 of the 3 impacted third molars
  • At least moderate pain within 5 hours after oral surgery procedure
  • Sufficiently alert to follow directions, communicate with study personnel and perform study procedures
  • If female, using an acceptable method of birth control and has a negative urine pregnancy test

Exclusion Criteria:

  • Previously treated patients who have discontinued treatment due to an adverse event
  • Patients who have had inadequate pain relief from tramadol HCl/acetaminophen or tramadol
  • Patients who have used pain medication (other than anesthesia) within 24 hours of receiving study medication, any long-acting over-the-counter pain medications within 3 days, or any pain medication after finishing oral surgery
  • Patients with known problems with taking opioid medications or acetaminophen
  • Patients with a history of abusing drugs or alcohol
  • Patients with an uncontrolled medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluation of total pain relief (TOTPAR), sum of pain intensity differences (PIDs) from baseline (SPID), and sum of total of pain relief and pain intensity differences (SPRID), 0 (baseline) to 6 hours after taking the study medication.

Secondary Outcome Measures

Outcome Measure
Evaluations of hourly pain relief (PAR); duration of pain relief; times to onset of any noticable decrease in pain and meaningful pain relief, time to remedication; patient overall medication assessment; and safety evaluations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

PriCara, Unit of Ortho-McNeil, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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