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

NCT06516094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Chronic Low-back Pain

Interventions

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

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Juan L Torres-Méndez · Clínica de Ozonoterapia RGH, A.C.

  • Raul Coca-Nuñez · CICMEX

  • Adelfia Urenda-Quezada · Imacen S.A. de C.V.

  • Ma. Dolores Alonso-Martinez · Servicios Avanzados de Investigación Medica Mediadvance S.C.

  • Ramon F Villalobos-Bojorquez · Clinical Research Institute, S.C.

  • Rodrigo Suárez-Otero · Consultorio Médico "Dr. Rodrigo Suárez Otero"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2025-01-01
Completion
2025-01-07

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516094 on ClinicalTrials.gov