Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01275248
Status:
TERMINATED
Last Update Posted:
2013-01-18
First Post:
2011-01-10
Brief Title:
Efficacy and Safety Study of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder
Sponsor:
Transcept Pharmaceuticals
Organization:
Transcept Pharmaceuticals
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder Who Have Not Adequately Responded To Treatment With A Serotonin Reuptake Inhibitor
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to assess the efficacy and safety of two doses of ondansetron 05 mg and 075 mg relative to placebo when administered twice daily as adjunctive therapy for adult patients with Obsessive-Compulsive Disorder OCD who have not adequately responded to treatment with a serotonin reuptake inhibitor SRI
Detailed Description:
This is a multi-center randomized double-blind placebo-controlled parallel-group study
A sufficient number of patients will be screened to obtain approximately 150 patients randomized to the double-blind portion of the study This study will consist of at least 6 weeks of retrospectively documented SRI treatment prior to screening 6 weeks of prospective SRI treatment after screening run-in but prior to randomization and 12 weeks of double-blind treatment with study drug ondansetron 05 mg twice a day ondansetron 075 mg twice a day or placebo twice a day
All patients will have been maintained on a single SRI at the same dose throughout the retrospective 6-week period and will continue the same SRI at the same dose throughout the run-in and double-blind treatment periods
The 12-week randomized double-blind placebo-controlled parallel-group study will be the core period for purposes of efficacy and short-term safety assessment Patients completing all 12 weeks of the core period will be offered an opportunity to participate in an extension period where they will continue to receive treatment for up to 30 months following the core period
Treatment assignment in the extension period will be as follows responders will continue on the same double-blind treatment to which they were assigned in the core period ondansetron 05 mg twice a day ondansetron 075 mg twice a day or placebo twice a day non-responders will be reassigned to continuing treatment according to their prior treatment assignment in the core period those who received placebo will be assigned to ondansetron 05 mg twice a day those who received ondansetron 05 mg twice a day will be assigned to ondansetron 075 mg twice a day and those who received ondansetron 075 mg twice a day will continue receiving ondansetron 075 mg twice a day Patients will receive treatment under double-blind conditions double-blind phase of the extension study until the core study is completed and the safety and efficacy of an ondansetron dose has been confirmed
If after the core study data analysis no treatment differences are found between ondansetron and placebo in the primary efficacy variable the extension study will be terminated If the core study results are positive for the primary efficacy endpoint and safety endpoints then patients participating in the double-blind phase of the extension study will be offered an opportunity to continue treatment under open-label conditions with the dose deemed efficacious and safe open-label phase of the extension study A Data Review Committee will be responsible for reviewing the core study analysis results providing a dose recommendation for the open-label phase of the extension study and for communicating the results and their recommendation to the participating institutional review boardsethics committees IRBsECs and investigators Patients may continue receiving treatment for up to 30 months or until the sponsor provides an alternative
A sufficient number of patients will be screened to obtain approximately 150 patients randomized to the double-blind portion of the study This study will consist of at least 6 weeks of retrospectively documented SRI treatment prior to screening 6 weeks of prospective SRI treatment after screening run-in but prior to randomization and 12 weeks of double-blind treatment with study drug ondansetron 05 mg twice a day ondansetron 075 mg twice a day or placebo twice a day
All patients will have been maintained on a single SRI at the same dose throughout the retrospective 6-week period and will continue the same SRI at the same dose throughout the run-in and double-blind treatment periods
The 12-week randomized double-blind placebo-controlled parallel-group study will be the core period for purposes of efficacy and short-term safety assessment Patients completing all 12 weeks of the core period will be offered an opportunity to participate in an extension period where they will continue to receive treatment for up to 30 months following the core period
Treatment assignment in the extension period will be as follows responders will continue on the same double-blind treatment to which they were assigned in the core period ondansetron 05 mg twice a day ondansetron 075 mg twice a day or placebo twice a day non-responders will be reassigned to continuing treatment according to their prior treatment assignment in the core period those who received placebo will be assigned to ondansetron 05 mg twice a day those who received ondansetron 05 mg twice a day will be assigned to ondansetron 075 mg twice a day and those who received ondansetron 075 mg twice a day will continue receiving ondansetron 075 mg twice a day Patients will receive treatment under double-blind conditions double-blind phase of the extension study until the core study is completed and the safety and efficacy of an ondansetron dose has been confirmed
If after the core study data analysis no treatment differences are found between ondansetron and placebo in the primary efficacy variable the extension study will be terminated If the core study results are positive for the primary efficacy endpoint and safety endpoints then patients participating in the double-blind phase of the extension study will be offered an opportunity to continue treatment under open-label conditions with the dose deemed efficacious and safe open-label phase of the extension study A Data Review Committee will be responsible for reviewing the core study analysis results providing a dose recommendation for the open-label phase of the extension study and for communicating the results and their recommendation to the participating institutional review boardsethics committees IRBsECs and investigators Patients may continue receiving treatment for up to 30 months or until the sponsor provides an alternative
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