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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236483
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 10, 2011
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Surgery, Oral Pain, Postoperative Drug: tramadol hydrochloride + acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2002
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236483

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
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Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00236483    
Other Study ID Numbers: CR002806
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: April 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Oral Surgery
Postoperative Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants