Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar

NCT02777970 | Completed Phase 4 Results

• 1 other identifier: DEX-TRA-06
• Study Type: interventional
• Target: 654
• Locations: 5 countries
• Sites: 18

Brief Summary

The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

Conditions

Acute Pain

Keywords

Acute pain; Acute moderate to severe pain; Postoperative pain; Dexketoprofen Tramadol; Dexketoprofen trometamol; Tramadol hydrochloride; Multimodal analgesia; Third molar extraction; Fixed drug combination; Paracetamol; Analgesics

Outcome Measures

Primary Outcomes (1)

• TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)

  TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6). The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.

  6 hours post-dose

Secondary Outcomes (5)

• % of Patients Achieving 50% of Max TOTPAR

  8 hours post-dose

• % of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose

  8 hours post-dose

• Time to Confirmed FPPAR (First Perceptible Pain Relief)

  2 hours post-dose

• % of Patients Requiring RM (Rescue Medication)

  8 hours post-dose

• PGE (Patient Global Evaluation)

  8 hours postdose

Study Arms (3)

Tramadol/Dexketoprofen

EXPERIMENTAL

Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose; Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.

Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol; Drug: Placebo

Tramadol/Paracetamol

ACTIVE COMPARATOR

Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose; Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose. .

Drug: Tramadol Hydrochloride/Paracetamol; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose; Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.

Drug: Placebo

Interventions

Tramadol Hydrochloride/Dexketoprofen Trometamol DRUG

Tramadol/Dexketoprofen

Tramadol Hydrochloride/Paracetamol DRUG

Tramadol/Paracetamol

Placebo DRUG

Placebo; Tramadol/Dexketoprofen; Tramadol/Paracetamol

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
• Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
• Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).

You may not qualify if:

• History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
• History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
• History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
• Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.

Sponsors & Collaborators

• Menarini Group: lead

Study Sites (18)

Dr. Tóth Bagi Zoltán Fogászati Rendeloje

Budapest, 1052, Hungary

Location

OralMed Studio Fogászati és Szájsebészeti Kft.

Budapest, 1126, Hungary

Location

Szegedi Tudományegyetem

Szeged, 6725, Hungary

Location

Ospedale Civile San Salvatore di L'Aquila

L’Aquila, 67100, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

Location

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

Location

Ars-Dent

Bialystok, 15-078, Poland

Location

Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic

Warsaw, 00-852, Poland

Location

Charme Clinique Klinika Stomatologii

Warsaw, 02-670, Poland

Location

Hospital Médico Quirúrgico de Conxo

A Coruña, 15702, Spain

Location

Centro Medico Teknon

Barcelona, 08022, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41009, Spain

Location

Universidad de Valencia

Valencia, 46010, Spain

Location

Birmingham Community Healthcare NHS Foundation Trust

Birmingham, B4 6NN, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XT, United Kingdom

Location

University of Manchester

Manchester, M15 6FH, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Publications (1)

• Gay-Escoda C, Hanna M, Montero A, Dietrich T, Milleri S, Giergiel E, Zoltan TB, Varrassi G. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open. 2019 Feb 19;9(2):e023715. doi: 10.1136/bmjopen-2018-023715.

  PMID: 30782886 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Tramadol; dexketoprofen trometamol; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Results Point of Contact

• Title: Dr. Angela Capriati (Clinical Sciences Director)
• Organization: Menarini Ricerche

acapriati@menarini-ricerche.it

+39 055 5680

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 19, 2016
• Study Start: April 1, 2016
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); HU (3); PL (3); ES (4); GB (4)