Efficacy and Safety of Etoricoxib/Cyanocobalamin Versus Etoricoxib for Acute Low Back Pain

What Was Tested

The trial (phase 3) is built around Cyanocobalamin (Vitamin B12).

Phase III longitudinal, multicenter, randomized, double-blind clinical trial.

It had two arms (groups): Etoricoxib+Cyanocobalamin (experimental) and Etoricoxib (active comparator).

Administered orally, 1 pill a day for 7 days.

The registry classes the interventions as drug.

More on the Plan

The adverse events related to the interventions will be registered during follow up.

Who Took Part

The registry lists 190 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Agree to participate in the study and give written informed consent. Patient with pain reported as moderate to severe intensity with ≥ 40 mm on the Visual Analog Scale (VAS). At least 4 points on the "Douleur Neuropathique-4 items" (DN-4) scale. Diagnosis of acute low back pain as a first-time episode or a previous episode 6 months before the enrollment day and lasting no more than 6 weeks. Women of childbearing potential under a medically acceptable method of contraception.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start; patients in whom the study drug is contraindicated for medical reasons; patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients (etoricoxib of cyanocobalamin).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-26 with completion listed for 2024-10-04.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of participants with treatment-related adverse events through the patient's diary record (time frame: 7 dyas).

It also tracked 8 secondary outcomes, for example Report the number of patients who present therapeutic failure during the study among the treatment groups.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 190 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.