A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Morphine; Tapentadol

Criteria

Inclusion Criteria:

• Female between 18 and 80 years of age;

• Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia;

• Anesthesiological and surgical procedures performed according to protocol;

• Moderate or severe baseline pain following hysterectomy on a Verbal Rating Scale (VRS) within 6 hours following the last possible application of morphine subcutaneous;

• Pain following hysterectomy of at least 4 on an 11-point Numeric Rating Scale (NRS) within 6 hours following the last possible application of morphine subcutaneous;

• American Society of Anesthesiologists (ASA) classification I-III.

Exclusion Criteria:

• Vaginal hysterectomy;

• Ongoing or known history of painful endometriosis;

• Known or suspected chronic pelvic pain syndrome;

• Previous abdominal or pelvic open surgery;

• History of seizure disorder or epilepsy;

• History of alcohol or drug abuse;

• Evidence of active infections that may spread to other areas of the body;

• severely impaired renal function, moderately or severely impaired hepatic function,

• Allergy or hypersensitivity to oxycodone, morphine, fentanyl hydromorphone, heparin, or any compound planned to be used during the anesthesia;

• Serious complication during surgery and up to randomization;

• Pre-operative use within 12hours prior to surgery or peri-operative use of non-steroidal anti-inflammatory drugs (NSAIDs);

• Treated regularly with opioid analgesic or non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to screening;