Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428168
Status:
TERMINATED
Last Update Posted:
2015-10-15
First Post:
2007-01-25
Brief Title:
Study to Examine the Effect of Betahistine on Body Weight Gain Due to Olanzapine Treatment
Sponsor:
OBEcure Ltd
Organization:
OBEcure Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Study to Examine the Effect of Betahistine on Body Weight Gain Due to Olanzapine Treatment
Status:
TERMINATED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim Analysis result indicated the study will not show a significant benefit of the study medication on the primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind placebo-controlled multicenter multinational study Approximately 78 subjects 39 per treatment group will be randomized into this 16 week study
A screening visit will be used to determine subject suitability for inclusion in the trial
Within 7 days of the screening visit subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups
Olanzapine OD plus betahistine 24 mg BID 48 mgday total
Olanzapine OD plus matching placebo BID
Double-blind treatment will continue for 16 weeks During this period olanzapine dosage will be determined according to the discretion of the treating physician In addition 5 study visits at 2 4 8 12 and 16 weeks will take place Study medication betahistine or matching placebo will be administered BID in the morning and together with olanzapine in the evening
The primary statistical hypothesis to be tested is that the mean change from Baseline to Week 16 will be different between the treatment and placebo groups
A screening visit will be used to determine subject suitability for inclusion in the trial
Within 7 days of the screening visit subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups
Olanzapine OD plus betahistine 24 mg BID 48 mgday total
Olanzapine OD plus matching placebo BID
Double-blind treatment will continue for 16 weeks During this period olanzapine dosage will be determined according to the discretion of the treating physician In addition 5 study visits at 2 4 8 12 and 16 weeks will take place Study medication betahistine or matching placebo will be administered BID in the morning and together with olanzapine in the evening
The primary statistical hypothesis to be tested is that the mean change from Baseline to Week 16 will be different between the treatment and placebo groups
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