Status:
COMPLETED
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Lead Sponsor:
Menarini Group
Conditions:
Acute Pain
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 age...
Detailed Description
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT01904149
Start Date
May 1 2013
End Date
May 1 2014
Last Update
April 1 2016
Active Locations (28)
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1
Bajcsy-Zsilinszky Kórház
Budapest, Hungary, 1106
2
University Hospital of Debrecen
Debrecen, Hungary, H-4012
3
Dr. Bugyi István Kórház
Szentes, Hungary, H-6600
4
Fejér megyei Szent György Kórház
Székesfehérvár, Hungary, 8000