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 range
18 Years – 70 Years
Sex
ALL
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:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.