Randomised, double-blind, placebo-controlled, active-treatment clinical trial to assess the analgesic efficacy and safety of an oral combination of ibuprofen (arginine) -tramadol HCl administered to patients with moderate to severe pain after undergoing dental surgery.

Conditions

Moderate to severe somatic pain.

Brief summary

Sum of the Pain Intensity Differences from the start of administration until after 12 hours (SPID0-12h), measured through the Visual Analogue Scale (VAS).

Detailed description

Pain intensity (PI) and pain intensity difference (PID) in scheduled assessment times up to 48 hours from the start of administration of the study medication., Area Under the Curve of pain intensity differences during the first 12 hours of study medication administration., Sum of the pain intensity differences regarding baseline, at 6 hours (SPID0-6h) from the start of the administration of the study medication., Patient responder rate, defined as the percentage of patients with a SPID(0-12h) ≥ δs, Time to first pain relief (Pain intensity ↓33%)., Proportion of patients using rescue medication., Total use of the different standardised levels of rescue medication from the start of treatment up to 12 and up to 48 hours later (measured in number of rescues required from each level)., Time to the first rescue administration from the start of administration of the study medication., Vital signs (body temperature, heart rate and blood pressure) and general physical examination., Laboratory abnormalities., Adverse events.

Related papers

No related papers found yet.

Interventions

DRUGEspididol 400 mg granulado para solución oral sabor menta

DRUGAdolonta 100 mg/ml solución oral

DRUGPL 1 Granules for oral solution

DRUGIbuprofen (arginine)/Tramadol HCl 400/37.5 mg granules for oral solution

DRUGPL 2 Oral solution

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Sum of the Pain Intensity Differences from the start of administration until after 12 hours (SPID0-12h), measured through the Visual Analogue Scale (VAS).	—

Secondary

Measure	Time frame
Pain intensity (PI) and pain intensity difference (PID) in scheduled assessment times up to 48 hours from the start of administration of the study medication., Area Under the Curve of pain intensity differences during the first 12 hours of study medication administration., Sum of the pain intensity differences regarding baseline, at 6 hours (SPID0-6h) from the start of the administration of the study medication., Patient responder rate, defined as the percentage of patients with a SPID(0-12h) ≥ δs, Time to first pain relief (Pain intensity ↓33%)., Proportion of patients using rescue medication., Total use of the different standardised levels of rescue medication from the start of treatment up to 12 and up to 48 hours later (measured in number of rescues required from each level)., Time to the first rescue administration from the start of administration of the study medication., Vital signs (body temperature, heart rate and blood pressure) and general physical examination., Laboratory a	—

Measure

Time frame

Pain intensity (PI) and pain intensity difference (PID) in scheduled assessment times up to 48 hours from the start of administration of the study medication., Area Under the Curve of pain intensity differences during the first 12 hours of study medication administration., Sum of the pain intensity differences regarding baseline, at 6 hours (SPID0-6h) from the start of the administration of the study medication., Patient responder rate, defined as the percentage of patients with a SPID(0-12h) ≥ δs, Time to first pain relief (Pain intensity ↓33%)., Proportion of patients using rescue medication., Total use of the different standardised levels of rescue medication from the start of treatment up to 12 and up to 48 hours later (measured in number of rescues required from each level)., Time to the first rescue administration from the start of administration of the study medication., Vital signs (body temperature, heart rate and blood pressure) and general physical examination., Laboratory a

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Countries

Spain

Outcome results

None listed