Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196339
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2005-09-12
Brief Title:
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as add-on therapy for prostate cancer patients with hot flashes following surgical or medical castration All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period
Detailed Description:
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as add-on therapy for prostate cancer in patients with mild to moderate vasomotor symptoms hot flashes following surgical or medical castration All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues LHRH agonists or LHRH antagonists with or without additional antiandrogen therapy Patients must have at least 21 moderate to severe hot flashes weekly
Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period In addition a brief physical evaluation will be done diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation
Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period In addition a brief physical evaluation will be done diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation
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