Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated… (NCT06863662) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm
Mexico136 participantsStarted 2024-09-18
Plain-language summary
This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial. The aim of the study is to evaluate the efficacy and safety of a fixed-dose combination of etoricoxib and tizanidine compared to etoricoxib alone in patients with acute low back pain associated with muscle spasms.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Willing to participate in the study and provide written informed consent.
* Diagnosis of acute low back pain, either as a first-time episode or following a previous episode within the past 6 months, with a duration not exceeding 6 weeks.
* Pain associated with lumbar muscle spasm, assessed through physical examination (muscle hypertonia and/or reflex scoliosis) and clinical history.
* Patient reports moderate to severe pain intensity (VAS ≥ 40 mm).
* Patients with a Neuropathic Pain Questionnaire (DN4) score \< 4.
* For women of childbearing age who are sexually active, the use of an acceptable contraceptive method (barrier and/or hormonal) as determined by the investigator.
* At the discretion of the Principal Investigator (PI) or treating physician, the patient is eligible for treatment with the investigational product and may benefit from it.
Exclusion Criteria:
* Patients with a history of hypersensitivity to any components of the investigational product (Etoricoxib/Tizanidine) or their derivatives (as reported in the medical history and clinical interview).
* Patients participating in another clinical trial involving an investigational treatment or who have participated in one within the past 2 weeks before the study begins.
* Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.).
* Patients for whom the investigational drug is contraindicated …
What they're measuring
1
Comparison of the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 of follow-up relative to baseline, within each treatment group.
Timeframe: 7 days
2
Number of participants reporting treatment-related adverse events, as documented in the patient diary.