Who is sponsoring NCT00744848?

NCT00744848 is sponsored by Pacira Pharmaceuticals, Inc.

What condition does NCT00744848 study?

NCT00744848 studies Hemorrhoids.

What drugs are being tested in NCT00744848?

Interventions: Bupivacaine HCl, SKY0402.

What is the status of NCT00744848?

NCT00744848 is currently COMPLETED.

Last reviewed 2013-07-03 · How we verify

Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

NCT00744848 Phase 3 COMPLETED Results posted

Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Details

Lead sponsor	Pacira Pharmaceuticals, Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	204
Start date	2008-08
Completion	2009-02

Conditions

Hemorrhoids

Interventions

Bupivacaine HCl
SKY0402

Primary outcomes

Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores — through 96 hours
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"

Countries

United States