Phase 3
Completed N=606
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Source: ClinicalTrials.gov NCT01904149 ↗Enrolled (actual)
606
Serious AEs
1.7%
Results posted
Apr 2015
Primary outcomePrimary: SPID8 (Sum of Pain Intensity Differences Over 8 Hours) — 241.8; 184.5; 157.3; 117.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SPID8 (Sum of Pain Intensity Differences Over 8 Hours) |
241.8; 184.5; 157.3; 117.0 | — |
| SECONDARY Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief) |
65.8; 47.7; 44.0; 30.7 | — |
| SECONDARY SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase) |
2273.0; 1965.2; 2035.0 | — |
| SECONDARY Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale) |
94.1; 82.7; 88.6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01904149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.