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NCT00196339 Clinical Trial

A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00196339
Other study ID # DR-PCA-201
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated July 20, 2016
Start date June 2005
Est. completion date January 2008

Study information
Verified date July 2016
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 315
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Prostate cancer patients who have undergone chemical or surgical castration

- History of hot flashes for at least 30 days

- Stable prostate cancer therapy for at least 45 days

Exclusion Criteria:

- Uncontrolled diabetes or severe COPD

- History of thromboembolic disease

- Liver or kidney dysfunction

- History or presence of cancer other than prostate cancer within the last 5 years

- Surgery within the last 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cyproterone acetate 5
Cyproterone acetate 5 mg
• Placebo
Matching placebo
• Cyproterone acetate 15
Cyproterone acetate 15 mg
• Cyproterone acetate 25
Cyproterone acetate 25 mg

Locations
Country Name City State
Canada Duramed Investigational Site Barrie Ontario
Canada Duramed Investigational Site Brantford Ontario
Canada Duramed Investigational Site Guelph Ontario
Canada Duramed Investigational Site Kelowna British Columbia
Canada Duramed Investigational Site Kentville Nova Scotia
Canada Duramed Investigational Site Markham Ontario
Canada Duramed Investigational Site Mirabel Quebec
Canada Duramed Investigational Site North Bay Ontario
Canada Duramed Investigational Site Oakville Ontario
Canada Duramed Investigational Site Oshawa Ontario
Canada Duramed Investigational Site Ottawa Ontario
Canada Duramed Investigational Site Pointe-Claire Quebec
Canada Duramed Investigational Site Saint John New Brunswick
Canada Duramed Investigational Site Sudbury Ontario
Canada Duramed Investigational Site Surrey British Columbia
Canada Duramed Investigational Site Toronto Ontario
Canada Duramed Investigational Site Toronto Ontario
Canada Duramed Investigational Site Vancouver British Columbia
Canada Duramed Investigational Site Vancouver British Columbia
Canada Duramed Investigational Site Victoria British Columbia
United States Duramed Investigational Site Albany New York
United States Duramed Investigational Site Allentown Pennsylvania
United States Duramed Investigational Site Anaheim California
United States Duramed Investigational Site Asheboro North Carolina
United States Duramed Investigational site Atlanta Georgia
United States Duramed Investigational Site Austin Texas
United States Duramed Investigational Site Aventura Florida
United States Duramed Investigational Site Bala Cynwyd Pennsylvania
United States Duramed Investigational Site Bayshore New York
United States Duramed Investigational Site Berwyn Illinois
United States Duramed Investigational Site Bethany Oklahoma
United States Duramed Investigational Site Birmingham Alabama
United States Duramed Investigational Site Birmingham Alabama
United States Duramed Investigational Site Brick New Jersey
United States Duramed Investigational Site Canfield Ohio
United States Duramed Investigational Site Canton Ohio
United States Duramed Investigational Site Charleston South Carolina
United States Duramed Investigational Site Chicago Illinois
United States Duramed Investigational Site Cincinatti Ohio
United States Duramed Investigational Site Coeur d'Alene Idaho
United States Duramed Investigational Site Concord North Carolina
United States Duramed Investigational Site Dallas Texas
United States Duramed Investigational Site Daytona Beach Florida
United States Duramed Investigational Site Denver Colorado
United States Duramed Investigational Site Denver Colorado
United States Duramed Investigational Site Des Moines Iowa
United States Duramed Investigational Site Edison New Jersey
United States Duramed Investigational Site Elmont New York
United States Duramed Investigational Site Fargo North Dakota
United States Duramed Investigational Site Fresno California
United States Duramed Investigational site Garden City New York
United States Duramed Investigational Site Greenbelt Maryland
United States Duramed Investigational Site Greenwood Indiana
United States Duramed Investigational Site Homewood Alabama
United States Duramed Investigational Site Houston Texas
United States Duramed Investigational Site Huntsville Alabama
United States Duramed Investigational Site Jackson Mississippi
United States Duramed Investigational Site Jeffersonville Indiana
United States Duramed Investigational Site Kankakee Illinois
United States Duramed Investigational Site Knoxville Tennessee
United States Duramed Investigational Site La Mesa California
United States Duramed Investigational Site Laguna Hills California
United States Duramed Investigational Site Laguna Woods California
United States Duramed Investigational Site Lancaster Pennsylvania
United States Duramed Investigational Site Las Vegas Nevada
United States Duramed Investigational Site Lawrenceville New Jersey
United States Duramed Investigational Site Little Rock Arkansas
United States Duramed Investigational Site Long Beach California
United States Duramed Investigational Site Los Angeles California
United States Duramed Investigational Site Middlebury Connecticut
United States Duramed Investigational Site Milwaukee Wisconsin
United States Duramed Investigational Site New Britain Connecticut
United States Duramed Investigational Site New Orleans Louisiana
United States Duramed Investigational Site New Port Richey Florida
United States Duramed Investigational Site New York New York
United States Duramed Investigational Site Newton Massachusetts
United States Duramed Investiational Site Ocala Florida
United States Duramed Investigational Site Ocala Florida
United States Duramed Investigational Site Ocala Florida
United States Duramed Investigational Site Oklahoma City Oklahoma
United States Duramed Investigational Site Overland Park Kansas
United States Duramed Investigational Site Peoria Illinois
United States Duramed Investigational Site Philadelphia Pennsylvania
United States Duramed Investigational Site Phoenix Arizona
United States Duramed Investigational Site Pittsburgh Pennsylvania
United States Duramed Investigational Site Pittsburgh Pennsylvania
United States Duramed Investigational Site Plantation Florida
United States Duramed Investigational Site Poughkeepsie New York
United States Duramed Investigational Site Providence Rhode Island
United States Duramed Investigational Site Raleigh North Carolina
United States Duramed Investigational Site Richmond Virginia
United States Duramed Investigational Site Salt Lake City Utah
United States Duramed Investigational Site Salt Lake City Utah
United States Duramed Investigational Site San Antonio Texas
United States Duramed Investigational Site San Bernardino California
United States Duramed Investigational Site San Diego California
United States Duramed Investigational Site Sarasota Florida
United States Duramed Investigational Site Sartell Minnesota
United States Duramed Investigational Site Seattle Washington
United States Duramed Investigational Site Sellersville Pennsylvania
United States Duramed Investigational Site Shreveport Louisiana
United States Duramed Investigational Site Spring Hill Florida
United States Duramed Investigational Site St. Joseph Michigan
United States Duramed Investigational Site St. Louis Missouri
United States Duramed Investigational Site St. Petersburg Florida
United States Duramed Investigational Site St. Petersburg Florida
United States Duramed Investigational Site State College Pennsylvania
United States Duramed Investigational Site Staten Island New York
United States Duramed Investigational Site Tacoma Washington
United States Duramed Investigational Site Tacoma Washington
United States Duramed Investigational Site Torrance California
United States Duramed Investigational Site Trumbull Connecticut
United States Duramed Investigational Site Tucson Arizona
United States Duramed Investigational Site Washington District of Columbia
United States Duramed Investigational Site Waterbury Connecticut
United States Duramed Investigational Site Watertown Massachusetts
United States Duramed Investigational Site Wheat Ridge Colorado
United States Duramed Investigational Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Duramed Research

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes Throughout study No
Primary To evaluate the safety compared to placebo Throughout study Yes
Primary Identify the lowest effective dose. End of study No
Secondary To compare the efficacy in reducing the severity of all hot flashes Throughout study No
Secondary To compare the efficacy in elimination of all hot flashes Throughout study No
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