search
Back to results

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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Dexketoprofen-single dose
Tramadol-single dose
Dexketoprofen/Tramadol-single dose
Dexketoprofen-multiple doses
Tramadol-multiple doses
Dexketoprofen/Tramadol-multiple doses
Sponsored by
Menarini Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Moderate to severe acute pain, Postoperative pain, Abdominal hysterectomy, Analgesics, Dexketoprofen, Tramadol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Bajcsy-Zsilinszky Kórház
  • University Hospital of Debrecen
  • Dr. Bugyi István Kórház
  • Fejér megyei Szent György Kórház
  • Juras Medicinas Centre
  • Riga East University Hospital Gynecology Clinic
  • Hospital of Lithuanian University of Health Sciences Kaunas
  • Vilniaus gimdymo namai
  • Samodzielny Publiczny Szpital Kliniczny nr 1
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Prywatna Klinika Polozniczo-Ginekologiczna
  • Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
  • Wojewodzki Szpital
  • Specjalistyczny Szpital im. E. Szczeklika
  • Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
  • Centralny Szpital Kliniczny MSW w Warszawie
  • Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
  • Genesys Fertility Center
  • Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
  • Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Clinic de Urgenta "Sfantul Pantelimon"
  • Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
  • Moscow Regional Research Institute of Obstetrics and Gynecol
  • FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA
  • GYNPOR, s.r.o.
  • Complejo Hospitalario Arquitecto Marcide
  • Hospital Universitario Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Active Comparator

Other

Other

Other

Arm Label

DKP/TRAM followed by DKP/TRAM

DKP followed by DKP

TRAM followed by TRAM

Placebo followed by DKP/TRAM

Placebo followed by DKP

Placebo followed by TRAM

Arm Description

Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses

Dexketoprofen-single dose followed by Dexketoprofen-multiple doses

Tramadol-single dose followed by Tramadol-multiple doses

Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses

Placebo single dose followed by Dexketoprofen-multiple doses

Placebo single dose followed by Tramadol-multiple doses

Outcomes

Primary Outcome Measures

SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
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

Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
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)
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)
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.

Full Information

First Posted
July 17, 2013
Last Updated
March 4, 2016
Sponsor
Menarini Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01904149
Brief Title
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Acronym
DAVID lap
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Moderate to severe acute pain, Postoperative pain, Abdominal hysterectomy, Analgesics, Dexketoprofen, Tramadol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DKP/TRAM followed by DKP/TRAM
Arm Type
Experimental
Arm Description
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
Arm Title
DKP followed by DKP
Arm Type
Active Comparator
Arm Description
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Arm Title
TRAM followed by TRAM
Arm Type
Active Comparator
Arm Description
Tramadol-single dose followed by Tramadol-multiple doses
Arm Title
Placebo followed by DKP/TRAM
Arm Type
Other
Arm Description
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
Arm Title
Placebo followed by DKP
Arm Type
Other
Arm Description
Placebo single dose followed by Dexketoprofen-multiple doses
Arm Title
Placebo followed by TRAM
Arm Type
Other
Arm Description
Placebo single dose followed by Tramadol-multiple doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo single oral dose (first 8 hours)
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen-single dose
Intervention Description
Dexketoprofen single oral dose (first 8 hours)
Intervention Type
Drug
Intervention Name(s)
Tramadol-single dose
Intervention Description
Tramadol single oral dose (first 8 hours)
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen/Tramadol-single dose
Intervention Description
Dexketoprofen/Tramadol single oral dose (first 8 hours)
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen-multiple doses
Intervention Description
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
Intervention Type
Drug
Intervention Name(s)
Tramadol-multiple doses
Intervention Description
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen/Tramadol-multiple doses
Intervention Description
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Primary Outcome Measure Information:
Title
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Description
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.
Time Frame
over 8 hours after the first dose
Secondary Outcome Measure Information:
Title
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Description
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.
Time Frame
over 8 hours after first dose
Title
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Description
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.
Time Frame
over 48 hours of the multiple-dose phase
Title
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
Description
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.
Time Frame
over 48 hours of the multiple-dose phase

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry J McQuay, Professor
Organizational Affiliation
Balliol College Oxford
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrew Moore, Professor
Organizational Affiliation
Pain Research & Nuffield Department of Anaesthetics - University of Oxford
Official's Role
Study Chair
Facility Information:
Facility Name
Bajcsy-Zsilinszky Kórház
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
University Hospital of Debrecen
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Dr. Bugyi István Kórház
City
Szentes
ZIP/Postal Code
H-6600
Country
Hungary
Facility Name
Fejér megyei Szent György Kórház
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Juras Medicinas Centre
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Riga East University Hospital Gynecology Clinic
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Vilniaus gimdymo namai
City
Vilnius
ZIP/Postal Code
LT-02106
Country
Lithuania
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Prywatna Klinika Polozniczo-Ginekologiczna
City
Bialystok
ZIP/Postal Code
15-224
Country
Poland
Facility Name
Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Wojewodzki Szpital
City
Przemyśl
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Specjalistyczny Szpital im. E. Szczeklika
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"
City
Bucharest
ZIP/Postal Code
011062
Country
Romania
Facility Name
Genesys Fertility Center
City
Bucharest
ZIP/Postal Code
011475
Country
Romania
Facility Name
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic de Urgenta "Sfantul Pantelimon"
City
Bucuresti
ZIP/Postal Code
21623
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Moscow Regional Research Institute of Obstetrics and Gynecol
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
GYNPOR, s.r.o.
City
Sliac
ZIP/Postal Code
962-31
Country
Slovakia
Facility Name
Complejo Hospitalario Arquitecto Marcide
City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Universitario Arnau de Vilanova
City
Lérida
ZIP/Postal Code
25198
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26801905
Citation
Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fulesdi B, Nizzardo A, Guerrero-Bayon C, Cuadripani S, Piza-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5. Erratum In: BMC Anesthesiol. 2017 Nov 30;17 (1):159.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs