Phase 4
N=654
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02777970 ↗Enrolled (actual)
654
Serious AEs
0.2%
Results posted
Mar 2021
Primary outcome: Primary: TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose) — 13.0; 9.2; 1.9 5-point Verbal Rating Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tramadol Hydrochloride/Dexketoprofen Trometamol (Drug); Tramadol Hydrochloride/Paracetamol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Menarini Group
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose) |
13.0; 9.2; 1.9 | — |
| SECONDARY % of Patients Achieving 50% of Max TOTPAR |
47.7; 35.5; 5.3 | — |
| SECONDARY % of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose |
40.0; 35.5; 9.9 | — |
| SECONDARY Time to Confirmed FPPAR (First Perceptible Pain Relief) |
21; 24 | — |
| SECONDARY % of Patients Requiring RM (Rescue Medication) |
51.2; 55.0; 88.5 | — |
| SECONDARY PGE (Patient Global Evaluation) |
3.6; 2.8; 1.5 | — |
Summary
The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
- Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
- Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).
Exclusion Criteria
- History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
- History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
- History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
- Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.
Data sourced from ClinicalTrials.gov (NCT02777970). 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.