Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).

Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

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

Details

• Lead Sponsor: Menarini Group
• Treatments: Analgesics; Dexketoprofen trometamol; Ketoprofen; Tramadol

Criteria

Inclusion Criteria:

• Female patients aged 18 to 75 years.

• Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.

• Patients experiencing pain at rest of at least moderate intensity the day after surgery.

Exclusion Criteria:

• Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.

• Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.

• Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.

• Patients using and not suitable to withdraw analgesics other than those specified in the protocol.

• Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.

• Breastfeeding women.