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

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Status and phase

Completed
Phase 4

Conditions

Acute Pain

Treatments

Drug: Placebo
Drug: Tramadol Hydrochloride/Paracetamol
Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT02777970
DEX-TRA-06

Details and patient eligibility

About

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.

Full description

The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.

In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio:

  • TRAM.HCL/DKP.TRIS
  • Paracetamol/TRAM.HCL
  • Placebo.

Enrollment

654 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

654 participants in 3 patient groups, including a placebo group

Tramadol/Dexketoprofen
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol
Tramadol/Paracetamol
Active Comparator group
Description:
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. .
Treatment:
Drug: Placebo
Drug: Tramadol Hydrochloride/Paracetamol
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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