Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low … (NCT05170841) | Clinical Trial Compass
CompletedPhase 4
Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
Italy538 participantsStarted 2020-09-17
Plain-language summary
A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Properly executed written informed consent.
✓. Male or female patients aged 18 years to 65 years.
✓. Patients with acute low back reporting pain of at least moderate intensity at Screening (NRS score ≥ 5). The onset of the current acute low back pain episode is within 48 hours prior to Screening.
✓. Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification.
✓. Naïve patients to any low back pain or patients with previous history of low back pain experiencing a new episode, preceded by a period of at least 2 months without any low back pain prior to Screening.
Exclusion criteria
✕. Females participating in the study must be either:
✕. Mentally competent and able to understand and give written informed consent prior to Screening.
✕. Compliant to undergo all visits and procedures scheduled in the Study.
✕. Patients who are judged by the Investigator not to be suitable candidates for the study treatments and the Rescue Medication (RM) based on their medical history, physical examination, Concomitant Medication (CM) and concurrent systemic diseases.
✕. Clinically significant abnormalities in the vital signs as per Investigator's judgment.
✕. Patients with acute low back pain and radiation to limb with presence of neurologic signs (focal weakness, asymmetry of reflexes, sensory loss in a dermatome, or loss of bowel, bladder, or sexual function) according to Quebec Task Force Classification.
What they're measuring
1
Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% From Drug Intake Till 8 Hours After the First Dose
Timeframe: 8 hours from first intake (referring to first 8 hours of Single Dose Phase)
Trial details
NCT IDNCT05170841
SponsorMenarini International Operations Luxembourg SA