Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
- Conditions
- Acute Pain
- Interventions
- Drug: Dexketoprofen/Tramadol-single doseDrug: Dexketoprofen-single doseDrug: PlaceboDrug: Tramadol-single doseDrug: Tramadol-multiple dosesDrug: Dexketoprofen/Tramadol-multiple dosesDrug: Dexketoprofen-multiple doses
- Registration Number
- NCT01904149
- Lead Sponsor
- Menarini Group
- 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 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.
- 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 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 combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 606
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo followed by TRAM Tramadol-multiple doses Placebo single dose followed by Tramadol-multiple doses DKP/TRAM followed by DKP/TRAM Dexketoprofen/Tramadol-single dose Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses DKP/TRAM followed by DKP/TRAM Dexketoprofen/Tramadol-multiple doses Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses DKP followed by DKP Dexketoprofen-single dose Dexketoprofen-single dose followed by Dexketoprofen-multiple doses Placebo followed by TRAM Placebo Placebo single dose followed by Tramadol-multiple doses DKP followed by DKP Dexketoprofen-multiple doses Dexketoprofen-single dose followed by Dexketoprofen-multiple doses TRAM followed by TRAM Tramadol-single dose Tramadol-single dose followed by Tramadol-multiple doses TRAM followed by TRAM Tramadol-multiple doses Tramadol-single dose followed by Tramadol-multiple doses Placebo followed by DKP/TRAM Placebo Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Placebo followed by DKP/TRAM Dexketoprofen/Tramadol-multiple doses Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Placebo followed by DKP Placebo Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP Dexketoprofen-multiple doses Placebo single dose followed by Dexketoprofen-multiple doses
- Primary Outcome Measures
Name Time Method SPID8 (Sum of Pain Intensity Differences Over 8 Hours) over 8 hours after the first dose Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
- Secondary Outcome Measures
Name Time Method Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief) over 8 hours after first dose Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.
The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase) over 48 hours of the multiple-dose phase Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.
PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale) over 48 hours of the multiple-dose phase Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS \< 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.
The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Trial Locations
- Locations (28)
Hospital Universitario Arnau de Vilanova
🇪🇸Lérida, Spain
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
🇵🇱Lublin, Lubelskie, Poland
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
🇷🇴Bucharest, Romania
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
🇷🇴Bucharest, Romania
Spitalul Clinic de Urgenta "Sfantul Pantelimon"
🇷🇴Bucuresti, Romania
Prywatna Klinika Polozniczo-Ginekologiczna
🇵🇱Bialystok, Poland
Specjalistyczny Szpital im. E. Szczeklika
🇵🇱Tarnow, Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
🇵🇱Lublin, Lubelskie, Poland
Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
🇵🇱Poznan, Poland
Centralny Szpital Kliniczny MSW w Warszawie
🇵🇱Warszawa, Poland
Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
🇷🇴Bucharest, Romania
Genesys Fertility Center
🇷🇴Bucharest, Romania
Complejo Hospitalario Arquitecto Marcide
🇪🇸Ferrol, Spain
FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA
🇷🇺Saint Petersburg, Russian Federation
Moscow Regional Research Institute of Obstetrics and Gynecol
🇷🇺Moscow, Russian Federation
Dr. Bugyi István Kórház
ðŸ‡ðŸ‡ºSzentes, Hungary
Bajcsy-Zsilinszky Kórház
ðŸ‡ðŸ‡ºBudapest, Hungary
University Hospital of Debrecen
ðŸ‡ðŸ‡ºDebrecen, Hungary
Fejér megyei Szent György Kórház
ðŸ‡ðŸ‡ºSzékesfehérvár, Hungary
Riga East University Hospital Gynecology Clinic
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas
🇱🇹Kaunas, Lithuania
Vilniaus gimdymo namai
🇱🇹Vilnius, Lithuania
Wojewodzki Szpital
🇵🇱Przemyśl, Poland
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Bucharest, Romania
Juras Medicinas Centre
🇱🇻Riga, Latvia
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
🇷🇴Targu-Mures, Romania
GYNPOR, s.r.o.
🇸🇰Sliac, Slovakia