Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517823
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Efficacy and Safety of EtoricoxibCyanocobalamin Versus Etoricoxib for Acute Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of the Fixed-Dose Combination of EtoricoxibCyanocobalamin Versus Etoricoxib in the Treatment of Patients With Acute Low Back Pain
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 safety of the Fixed-Dose Combination of EtoricoxibCyanocobalamin Versus Etoricoxib in Patients With Acute Low Back Pain
Detailed Description:
Researchers will compare the fixed-dose combination of EtoricoxibCyanocobalamin versus Etoricoxib in acute low back pain by comparing the proportion of patients that reported an improvement in pain during the 7 days of follow up The adverse events related to the interventions will be registered during follow up
Participants will
Be randomized into one of the 2 intervention groups A or B
Visit the clinic in 3 occasions day 0 day 3 of follow up and day 7 of follow up
In case needed the patient could take 50 mg of tramadol as a rescue medication previous authorization of de principal investigator
Participants will
Be randomized into one of the 2 intervention groups A or B
Visit the clinic in 3 occasions day 0 day 3 of follow up and day 7 of follow up
In case needed the patient could take 50 mg of tramadol as a rescue medication previous authorization of de principal investigator
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