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Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (DAVID lap)

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ClinicalTrials.gov Identifier: NCT01904149
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Pain Drug: Placebo Drug: Dexketoprofen-single dose Drug: Tramadol-single dose Drug: Dexketoprofen/Tramadol-single dose Drug: Dexketoprofen-multiple doses Drug: Tramadol-multiple doses Drug: Dexketoprofen/Tramadol-multiple doses Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DKP/TRAM followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
Drug: Dexketoprofen/Tramadol-single dose
Dexketoprofen/Tramadol single oral dose (first 8 hours)

Drug: Dexketoprofen/Tramadol-multiple doses
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Active Comparator: DKP followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Drug: Dexketoprofen-single dose
Dexketoprofen single oral dose (first 8 hours)

Drug: Dexketoprofen-multiple doses
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)

Active Comparator: TRAM followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
Drug: Tramadol-single dose
Tramadol single oral dose (first 8 hours)

Drug: Tramadol-multiple doses
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Placebo followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
Drug: Placebo
Placebo single oral dose (first 8 hours)

Drug: Dexketoprofen/Tramadol-multiple doses
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Placebo followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
Drug: Placebo
Placebo single oral dose (first 8 hours)

Drug: Dexketoprofen-multiple doses
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)

Placebo followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
Drug: Placebo
Placebo single oral dose (first 8 hours)

Drug: Tramadol-multiple doses
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)




Primary Outcome Measures :
  1. SPID8 (Sum of Pain Intensity Differences Over 8 Hours) [ Time Frame: 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 :
  1. Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief) [ Time Frame: 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.


  2. SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase) [ Time Frame: 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.


  3. Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale) [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904149


Locations
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Hungary
Bajcsy-Zsilinszky Kórház
Budapest, Hungary, 1106
University Hospital of Debrecen
Debrecen, Hungary, H-4012
Dr. Bugyi István Kórház
Szentes, Hungary, H-6600
Fejér megyei Szent György Kórház
Székesfehérvár, Hungary, 8000
Latvia
Juras Medicinas Centre
Riga, Latvia, LV-1005
Riga East University Hospital Gynecology Clinic
Riga, Latvia, LV-1038
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Lithuania, LT-50009
Vilniaus gimdymo namai
Vilnius, Lithuania, LT-02106
Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, Lubelskie, Poland, 20-081
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lubelskie, Poland, 20-954
Prywatna Klinika Polozniczo-Ginekologiczna
Bialystok, Poland, 15-224
Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
Poznan, Poland, 60-535
Wojewodzki Szpital
Przemyśl, Poland, 37-700
Specjalistyczny Szpital im. E. Szczeklika
Tarnow, Poland, 33-100
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
Warszawa, Poland, 00-909
Centralny Szpital Kliniczny MSW w Warszawie
Warszawa, Poland, 02-507
Romania
Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
Bucharest, Romania, 011062
Genesys Fertility Center
Bucharest, Romania, 011475
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
Bucharest, Romania, 020475
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
Bucharest, Romania, 020475
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania, 050098
Spitalul Clinic de Urgenta "Sfantul Pantelimon"
Bucuresti, Romania, 21623
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
Targu-Mures, Romania, 540136
Russian Federation
Moscow Regional Research Institute of Obstetrics and Gynecol
Moscow, Russian Federation, 101000
FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA
Saint Petersburg, Russian Federation, 194291
Slovakia
GYNPOR, s.r.o.
Sliac, Slovakia, 962-31
Spain
Complejo Hospitalario Arquitecto Marcide
Ferrol, Spain, 15405
Hospital Universitario Arnau de Vilanova
Lérida, Spain, 25198
Sponsors and Collaborators
Menarini Group
Investigators
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Study Chair: Henry J McQuay, Professor Balliol College Oxford
Study Chair: Andrew Moore, Professor Pain Research & Nuffield Department of Anaesthetics - University of Oxford

Publications of Results:
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Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01904149     History of Changes
Other Study ID Numbers: DEX-TRA-04
2012-004545-32 ( EudraCT Number )
First Posted: July 22, 2013    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by Menarini Group:
Moderate to severe acute pain
Postoperative pain
Abdominal hysterectomy
Analgesics
Dexketoprofen
Tramadol

Additional relevant MeSH terms:
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Tramadol
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Dexketoprofen trometamol
Ketoprofen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action