Pain, Postoperative Clinical Trial
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
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.
Status | Completed |
Enrollment | 456 |
Est. completion date | February 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
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):250-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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