Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516094
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
Efficacy and Safety in the Combination of Celecoxib Pregabalin Vitamin B for Low Back Chronic Pain
Sponsor:
None
Organization:
None
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:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 CelecoxibPregabalinVitamin 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 ABC 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 ABC 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None