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

Menarini

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: Dexketoprofen-multiple doses; Drug: Dexketoprofen/Tramadol-single dose; Drug: Dexketoprofen/Tramadol-multiple doses; Drug: Placebo; Drug: Dexketoprofen-single dose; Drug: Tramadol-single dose; Drug: Tramadol-multiple doses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01904149

2012-004545-32 (EudraCT Number)

DEX-TRA-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 606 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients aged 18 to 75 years.
• Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
• 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.
• Breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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606 participants in 6 patient groups

DKP/TRAM followed by DKP/TRAM

Experimental group

Description:

Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses

Treatment:

Drug: Dexketoprofen/Tramadol-single dose

Drug: Dexketoprofen/Tramadol-multiple doses

DKP followed by DKP

Active Comparator group

Description:

Dexketoprofen-single dose followed by Dexketoprofen-multiple doses

Treatment:

Drug: Dexketoprofen-single dose

Drug: Dexketoprofen-multiple doses

TRAM followed by TRAM

Active Comparator group

Description:

Tramadol-single dose followed by Tramadol-multiple doses

Treatment:

Drug: Tramadol-single dose

Drug: Tramadol-multiple doses

Placebo followed by DKP/TRAM

Other group

Description:

Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses

Treatment:

Drug: Placebo

Drug: Dexketoprofen/Tramadol-multiple doses

Placebo followed by DKP

Other group

Description:

Placebo single dose followed by Dexketoprofen-multiple doses

Treatment:

Drug: Placebo

Drug: Dexketoprofen-multiple doses

Placebo followed by TRAM

Other group

Description:

Placebo single dose followed by Tramadol-multiple doses

Treatment:

Drug: Placebo

Drug: Tramadol-multiple doses