NCT06516094

Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain

Efficacy and Safety Study of Celecoxib / Pregabalin / Vitamin B Fixed Dose Combination Versus Celecoxib + Vitamin B Versus Pregabalin + Vitamin B in the Management of Chronic Low Back Pain Mixed Component

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and security of the drug combination of Celecoxib / Pregabalin / Vitamin B versus Celecoxib + Vitamin B, versus Pregabalin + Vitamin B in the treatment of chronic low back pain.

Detailed description

Researchers will compare the fixed-dose combination of Celecoxib/Pregabalin/Vitamin B versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B for chronic low back pain. The adverse events related to the interventions would be registered in each follow up visit. Participants will: * Be randomized into one of the 3 intervention groups (A,B,C) once a day for 12 weeks * If needed the dose could be escaleted twice a day. * Visit the clinic at weeks 2, 4, 8 and 12 for checkups and follow up

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DRUG	Celecoxib+Pregabalin+Vitamin B fixed dose	One tablet of 200 mg / 150 mg / 100 mg / 50 mg / 0.50 mg + 1 capsule of placebo once a day
DRUG	Celecoxib + Vitamin B fixed dose	One capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day
DRUG	Pregabalin + Vitamin B fixed dose	One capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day

Timeline

• Start date: 2024-04-11
• Primary completion: 2025-01-01
• Completion: 2025-01-07
• First posted: 2024-07-23
• Last updated: 2025-04-04

Locations

1 site across 1 country: Mexico