Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 1:42 AM
NCT ID:
NCT06516094
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
Study:
NCT06516094
Study Brief:
Protocol Section:
NCT06516094