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

Launched by MENARINI GROUP · Jul 17, 2013

Keywords

ClinConnect Summary

In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:

* DKP/TRAM followed by DKP/TRAM;
* DKP followed by DKP;
* TRAM followed by TRAM;
* placebo followed by DKP;
* placebo followed by TRAM;
* placebo followed by DKP/TRAM;

The analyses of endpoints pertinent to the single dose phase were performed com...

Gender

FEMALE

Eligibility 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.