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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236483
First received: October 7, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Surgery, Oral
Pain, Postoperative
Drug: tramadol hydrochloride + acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 456
Study Start Date: November 2002
Study Completion Date: February 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236483

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00236483     History of Changes
Other Study ID Numbers: CR002806
Study First Received: October 7, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Oral Surgery
Analgesics
Postoperative Pain
dental

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 26, 2014