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Completed

NCT Number: NCT01902134

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fakultni nemocnice Brno, Brno, Czechia

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About this study

In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:

  • DKP/TRAM followed by DKP/TRAM;
  • DKP followed by DKP;
  • TRAM followed by TRAM;
  • placebo followed by DKP;
  • placebo followed by TRAM;
  • placebo followed by DKP/TRAM;

The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Drug

Placebo single oral dose (first 8 hours)

Tramadol-single dose

Drug

Tramadol single oral dose (first 8 hours)

Dexketoprofen-single dose

Drug

Dexketoprofen single oral dose (first 8 hours)

Dexketoprofen/Tramadol-single dose

Drug

Dexketoprofen/Tramadol oral single dose (first 8 hours)

Tramadol-multiple doses

Drug

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

Dexketoprofen-multiple doses

Drug

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

Dexketoprofen/Tramadol-multiple doses

Drug

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

Primary outcomes

  1. SPID8 (Sum of Pain Intensity Differences Over 8 Hours)

    Time frame: over 8 hours after the first dose

    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.

Secondary outcomes

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

    Time frame: over 48 hours of the multiple-dose phase

    Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.

    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 every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.

    The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

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

    Time frame: over 48 hours of the multiple-dose phase

    Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.

    The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

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

    Time frame: over 8 hours after the first dose

    Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.

    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.

Sponsors and collaborators

Lead sponsor

Menarini Group

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain After Elective Unilateral Total Hip Arthroplasty

Acronym: DAVID-art

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2013
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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