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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Acetaminophen; Tramadol

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