Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-01-04 @ 6:56 PM
Study NCT ID:
NCT06516094
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
Sponsor:
Laboratorios Silanes S.A. de C.V.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: