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

NCT01902134 | Completed Phase 3 Results

• 2 other identifiers: DEX-TRA-052012-004548-31
• Study Type: interventional
• Target: 641
• Locations: 10 countries
• Sites: 37

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 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty 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; Hip arthroplasty; 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)

• SPID48 (Sum of Pain Intensity Differences Over First 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

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

  over 8 hours after the first dose

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

Tramadol-single dose DRUG

Tramadol single oral dose (first 8 hours)

TRAM followed by TRAM

Dexketoprofen-single dose DRUG

Dexketoprofen single oral dose (first 8 hours)

DKP followed by DKP

Dexketoprofen/Tramadol-single dose DRUG

Dexketoprofen/Tramadol oral single dose (first 8 hours)

DKP/TRAM followed by DKP/TRAM

Tramadol-multiple doses DRUG

Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

Placebo followed by TRAM; TRAM followed by TRAM

Dexketoprofen-multiple doses DRUG

Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses)

DKP followed by DKP; Placebo followed by DKP

Dexketoprofen/Tramadol-multiple doses DRUG

Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 to 80 years. Females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method.
• Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis.
• 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.
• Pregnant and breastfeeding women.

Sponsors & Collaborators

• Menarini Group: lead

Study Sites (37)

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Urazova nemocnice v Brne

Brno, 662 50, Czechia

Location

Nemocnice Jihlava, p.o.

Jihlava, 586 33, Czechia

Location

Oblastni nemocnice Kladno

Kladno, 272 59, Czechia

Location

Oblastni nemocnice Mlada Boleslav a.s.

Mladá Boleslav, 293 50, Czechia

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, 65929, Germany

Location

Uzsoki Hospital, Department of Orthopaedics

Budapest, 1145, Hungary

Location

University of Debrecen

Debrecen, H-4012, Hungary

Location

PTE KK Trauma Központ-Balesetsebészeti és Kézsebésze

Pécs, 7632, Hungary

Location

Fejér Megyei Szent György Kórház

Székesfehérvár, 8000, Hungary

Location

MÁV Kórház és Rendelőintézet, Ortopédiai osztály

Szolnok, 5000, Hungary

Location

Liepaja Regional Hospital

Liepāja, LV-3414, Latvia

Location

Riga's 2nd Hospital

Riga, LV-1004, Latvia

Location

Hospital of Traumatology and Orthopaedics

Riga, LV-1005, Latvia

Location

Vidzemes Hospital

Valmiera, LV-4201, Latvia

Location

Kaunas Clinical Hospital

Kaunas, LT-44320, Lithuania

Location

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, LT-50009, Lithuania

Location

Klaipedos Universitetine ligonine

Klaipėda, 92288, Lithuania

Location

Respublikine Vilniaus universitetine ligonine

Vilnius, LT-04130, Lithuania

Location

Uniwersytecki Szpital Klioniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

Warminskie Centrum Ortopedyczne

Elblag, 82-300, Poland

Location

Wojewodzki Szpital Specjalistyczny

Lublin, 20-718, Poland

Location

Specjalistyczny Szpital im. E. Szczeklika

Tarnów, 33-100, Poland

Location

Urazowo - Ortopedycznej Wojewodzkiego Szpitala Specjalistycznego we Wrocławiu

Wroclaw, 51-128, Poland

Location

Medical University of Lodz

Lodz, Łódź Voivodeship, 91-002, Poland

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Institute for orthopedic Surgery Banjica [Ortopedic Surgery

Belgrade, 11000, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinic for Orthopedic Surgery and Trauma Bul. Dr Zorana Djindjica

Niš, 18000, Serbia

Location

Hospital L'Esperança. Parc de Salut Mar.

Barcelona, 08024, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

China Medical University Hospital [Orthopedic]

Taichung, 404, Taiwan

Location

Kuang Tien General Hospital

Taichung, 433, Taiwan

Location

Cherkaska oblasna likarnia

Cherkasy, 18009, Ukraine

Location

Instytut patologii khrebta ta suglobiv im. prof. M.I. Sytenka NAMN Ukraine

Kharkiv, 61024, Ukraine

Location

Kyivska oblasna klinichna likarnia

Kyiv, 04107, Ukraine

Location

Sevastopolska miska likarnia №9

Sevastopol, 99018, Ukraine

Location

Related Publications (1)

• McQuay HJ, Moore RA, Berta A, Gainutdinovs O, Fulesdi B, Porvaneckas N, Petronis S, Mitkovic M, Bucsi L, Samson L, Zegunis V, Ankin ML, Bertolotti M, Piza-Vallespir B, Cuadripani S, Contini MP, Nizzardo A. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016 Feb;116(2):269-76. doi: 10.1093/bja/aev457.

  PMID: 26787797 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

• Andrew Moore, Professor

  Pain Research & Nuffield Department of Anaesthetics - University of Oxford

  STUDY CHAIR

• Henry J McQuay, Professor

  Balliol College 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 15, 2013
• First Posted: July 18, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 7, 2016
• Results First Posted: April 1, 2015

Record last verified: 2016-02

Locations

LA (4); ES (2); UA (4); LI (4); CZ (5); SE (4); DE (1); TW (2); PL (6); HU (5)