NCT00236483

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_4

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

November 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

June 8, 2011

Conditions

Surgery, OralPain, Postoperative

Keywords

Oral SurgeryAnalgesicsPostoperative Paindental

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

tramadol hydrochloride + acetaminophenDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fricke JR Jr, Hewitt DJ, Jordan DM, Fisher A, Rosenthal NR. A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain. Pain. 2004 Jun;109(3):250-257. doi: 10.1016/j.pain.2004.01.004.

    PMID: 15157685RESULT

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultracet

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

November 1, 2002

Study Completion

February 1, 2003

Last Updated

June 10, 2011

Record last verified: 2010-04