Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Surgery, Oral
Pain, Postoperative
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 hydr...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00236483
Start Date
November 1 2002
End Date
February 1 2003
Last Update
June 10 2011
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