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

NCT01904149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2016-04-01

Study results available
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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

Interventions

DRUG

Placebo

Placebo single oral dose (first 8 hours)

DRUG

Dexketoprofen-single dose

Dexketoprofen single oral dose (first 8 hours)

DRUG

Tramadol-single dose

Tramadol single oral dose (first 8 hours)

DRUG

Dexketoprofen/Tramadol-single dose

Dexketoprofen/Tramadol single oral dose (first 8 hours)

DRUG

Dexketoprofen-multiple doses

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

DRUG

Tramadol-multiple doses

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

DRUG

Dexketoprofen/Tramadol-multiple doses

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

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Henry J McQuay, Professor · Balliol College Oxford

  • Andrew Moore, Professor · Pain Research & Nuffield Department of Anaesthetics - University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904149 on ClinicalTrials.gov