Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506136
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Evaluation of Fluoxetine in Refractory Constipation Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy of Fluoxetine in the Treatment of Refractory Constipation a Multicenter Randomized Double-blind Placebo-controlled Trial
Status:
NOT_YET_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:
EFoRT
Brief Summary:
The goal of this clinical trial is to determine if fluoxetine is effective in treating refractory constipation in adults It will also assess the safety profile of fluoxetine when used for this condition The main questions it aims to answer are
Does fluoxetine improve bowel movement frequency and Complete Spontaneous Bowel Movements CSBM in participants with refractory constipation What adverse effects do participants experience while taking fluoxetine Researchers will compare fluoxetine to a placebo a look-alike substance that contains no active drug to evaluate its efficacy and safety in treating chronic constipation
Participants will
Take fluoxetine or a placebo daily for 12 weeks Visit the clinic every 4 weeks for checkups and tests Maintain a diary of their CSBM Spontaneous Bowel Movements SBM bowel movements stool consistency and any side effects experienced
Does fluoxetine improve bowel movement frequency and Complete Spontaneous Bowel Movements CSBM in participants with refractory constipation What adverse effects do participants experience while taking fluoxetine Researchers will compare fluoxetine to a placebo a look-alike substance that contains no active drug to evaluate its efficacy and safety in treating chronic constipation
Participants will
Take fluoxetine or a placebo daily for 12 weeks Visit the clinic every 4 weeks for checkups and tests Maintain a diary of their CSBM Spontaneous Bowel Movements SBM bowel movements stool consistency and any side effects experienced
Detailed Description:
None
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