Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain

PHASE4CompletedINTERVENTIONAL
Enrollment

538

Participants

Timeline

Start Date

September 17, 2020

Primary Completion Date

May 4, 2022

Study Completion Date

May 4, 2022

Conditions
Low Back Pain
Interventions
DRUG

Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg

Administered as one single tablet to be taken every 8 hours

DRUG

Tramadol Hydrochloride 100 mg

Administered as two capsules with 50 mg each to be taken every 8 hours

DRUG

Placebo

Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg

Trial Locations (1)

67100

University of L'Aquila, L’Aquila

All Listed Sponsors
lead

Menarini International Operations Luxembourg SA

INDUSTRY

NCT05170841 - Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain | Biotech Hunter | Biotech Hunter