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Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (DAVID-art)

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ClinicalTrials.gov Identifier: NCT01902134
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : April 1, 2015
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Menarini Group

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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Placebo Drug: Tramadol-single dose Drug: Dexketoprofen-single dose Drug: Dexketoprofen/Tramadol-single dose Drug: Tramadol-multiple doses Drug: Dexketoprofen-multiple doses Drug: Dexketoprofen/Tramadol-multiple doses Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DKP/TRAM followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
Drug: Dexketoprofen/Tramadol-single dose
Dexketoprofen/Tramadol oral single dose (first 8 hours)

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

Active Comparator: DKP followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Drug: Dexketoprofen-single dose
Dexketoprofen single oral dose (first 8 hours)

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

Active Comparator: TRAM followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
Drug: Tramadol-single dose
Tramadol single oral dose (first 8 hours)

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

Placebo followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
Drug: Placebo
Placebo single oral dose (first 8 hours)

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

Placebo followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
Drug: Placebo
Placebo single oral dose (first 8 hours)

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

Placebo followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
Drug: Placebo
Placebo single oral dose (first 8 hours)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902134


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Sponsors and Collaborators
Menarini Group
Investigators
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Study Chair: Andrew Moore, Professor Pain Research & Nuffield Department of Anaesthetics - University of Oxford
Study Chair: Henry J McQuay, Professor Balliol College Oxford

Additional Information:
Publications of Results:
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Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01902134     History of Changes
Other Study ID Numbers: DEX-TRA-05
2012-004548-31 ( EudraCT Number )
First Posted: July 18, 2013    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: March 7, 2016
Last Verified: February 2016

Keywords provided by Menarini Group:
Moderate to severe acute pain
Postoperative pain
Hip arthroplasty
Analgesics
Dexketoprofen
Tramadol

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Tramadol
Dexketoprofen trometamol
Ketoprofen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action