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

NCT01904149 | Completed Phase 3 Results

• 2 other identifiers: DEX-TRA-042012-004545-32
• Study Type: interventional
• Target: 606
• Locations: 8 countries
• Sites: 28

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.

Conditions

Acute Pain

Keywords

Moderate to severe acute pain; Postoperative pain; Abdominal hysterectomy; Analgesics; Dexketoprofen; Tramadol

Outcome Measures

Primary Outcomes (1)

• 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.

  over 8 hours after the first dose

Secondary Outcomes (3)

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

  over 8 hours after first dose

• SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)

  over 48 hours of the multiple-dose phase

• Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)

  over 48 hours of the multiple-dose phase

Study Arms (6)

DKP/TRAM followed by DKP/TRAM

EXPERIMENTAL

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

Drug: Dexketoprofen/Tramadol-single dose; Drug: Dexketoprofen/Tramadol-multiple doses

DKP followed by DKP

ACTIVE COMPARATOR

Dexketoprofen-single dose followed by Dexketoprofen-multiple doses

Drug: Dexketoprofen-single dose; Drug: Dexketoprofen-multiple doses

TRAM followed by TRAM

ACTIVE COMPARATOR

Tramadol-single dose followed by Tramadol-multiple doses

Drug: Tramadol-single dose; Drug: Tramadol-multiple doses

Placebo followed by DKP/TRAM

OTHER

Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses

Drug: Placebo; Drug: Dexketoprofen/Tramadol-multiple doses

Placebo followed by DKP

OTHER

Placebo single dose followed by Dexketoprofen-multiple doses

Drug: Placebo; Drug: Dexketoprofen-multiple doses

Placebo followed by TRAM

OTHER

Placebo single dose followed by Tramadol-multiple doses

Drug: Placebo; Drug: Tramadol-multiple doses

Interventions

Placebo DRUG

Placebo single oral dose (first 8 hours)

Placebo followed by DKP; Placebo followed by DKP/TRAM; Placebo followed by TRAM

Dexketoprofen-single dose DRUG

Dexketoprofen single oral dose (first 8 hours)

DKP followed by DKP

Tramadol-single dose DRUG

Tramadol single oral dose (first 8 hours)

TRAM followed by TRAM

Dexketoprofen/Tramadol-single dose DRUG

Dexketoprofen/Tramadol single oral dose (first 8 hours)

DKP/TRAM followed by DKP/TRAM

Dexketoprofen-multiple doses DRUG

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

DKP followed by DKP; Placebo followed by DKP

Tramadol-multiple doses DRUG

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

Placebo followed by TRAM; TRAM followed by TRAM

Dexketoprofen/Tramadol-multiple doses DRUG

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

DKP/TRAM followed by DKP/TRAM; Placebo followed by DKP/TRAM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menarini Group: lead

Study Sites (28)

Bajcsy-Zsilinszky Kórház

Budapest, 1106, Hungary

Location

University Hospital of Debrecen

Debrecen, H-4012, Hungary

Location

Dr. Bugyi István Kórház

Szentes, H-6600, Hungary

Location

Fejér megyei Szent György Kórház

Székesfehérvár, 8000, Hungary

Location

Juras Medicinas Centre

Riga, LV-1005, Latvia

Location

Riga East University Hospital Gynecology Clinic

Riga, LV-1038, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, LT-50009, Lithuania

Location

Vilniaus gimdymo namai

Vilnius, LT-02106, Lithuania

Location

Samodzielny Publiczny Szpital Kliniczny nr 1

Lublin, Lublin Voivodeship, 20-081, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, Lublin Voivodeship, 20-954, Poland

Location

Prywatna Klinika Polozniczo-Ginekologiczna

Bialystok, 15-224, Poland

Location

Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu

Poznan, 60-535, Poland

Location

Wojewodzki Szpital

Przemyśl, 37-700, Poland

Location

Specjalistyczny Szpital im. E. Szczeklika

Tarnów, 33-100, Poland

Location

Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini

Warsaw, 00-909, Poland

Location

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, 02-507, Poland

Location

Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"

Bucharest, 011062, Romania

Location

Genesys Fertility Center

Bucharest, 011475, Romania

Location

Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II

Bucharest, 020475, Romania

Location

Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I

Bucharest, 020475, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

Spitalul Clinic de Urgenta "Sfantul Pantelimon"

Bucharest, 21623, Romania

Location

Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I

Târgu Mureş, 540136, Romania

Location

Moscow Regional Research Institute of Obstetrics and Gynecol

Moscow, 101000, Russia

Location

FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA

Saint Petersburg, 194291, Russia

Location

GYNPOR, s.r.o.

Sliač, 962-31, Slovakia

Location

Hospital Universitario Arnau de Vilanova

Lleida, Lérida, 25198, Spain

Location

Complejo Hospitalario Arquitecto Marcide

Ferrol, 15405, Spain

Location

Related Publications (1)

• 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.

  PMID: 26801905 RESULT

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Dr. Angela Capriati, Corporate Director of Clinical Research
• Organization: Menarini Ricerche S.p.A.

ACapriati@menarini-ricerche.it

+3905556809933

Study Officials

• Henry J McQuay, Professor

  Balliol College Oxford

  STUDY CHAIR

• Andrew Moore, Professor

  Pain Research & Nuffield Department of Anaesthetics - University of Oxford

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 1, 2016
• Results First Posted: April 1, 2015

Record last verified: 2016-03

Locations

LA (2); LI (2); RO (7); PL (8); HU (4); RU (2); SL (1); ES (2)