Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620562
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Improving Efficacity of Sleeve Gastrectomy With NaltrexoneBupropion Extended-release Tablet
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Efficacity of Sleeve Gastrectomy With NaltrexoneBupropion Extended-release Tablet - A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to assess the impact of combination therapy with Naltrexone-Bupropion NB in the post-operative period of sleeve gastrectomy SG on a weight loss b resolution of comorbidities and c eating behaviors
Researchers will compare SG-NB group with SG-placebo group to see if they experience significantly higher excess weight loss EWL at 12 and 24 months and if there is a significantly higher percentage of patients with an EWL above 50 in the SG-NB group versus in the SG-placebo group
Participants will be randomized 11 to SG in combination with NB versus SG with placebo Patients will be started one month after surgery on a progressive dose of NaltrexoneBupropion extended-release or placebo Duration of therapy will be 24 monthsBoth groups will benefit from behavioral and nutritional support
Researchers will compare SG-NB group with SG-placebo group to see if they experience significantly higher excess weight loss EWL at 12 and 24 months and if there is a significantly higher percentage of patients with an EWL above 50 in the SG-NB group versus in the SG-placebo group
Participants will be randomized 11 to SG in combination with NB versus SG with placebo Patients will be started one month after surgery on a progressive dose of NaltrexoneBupropion extended-release or placebo Duration of therapy will be 24 monthsBoth groups will benefit from behavioral and nutritional support
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