Clinical trial NCT00196339: A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
hot flashes
hot flushes
vasomotor symptoms
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 315
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
timeFrame: Throughout study
measure: To evaluate the safety compared to placebo
timeFrame: Throughout study
measure: Identify the lowest effective dose.
timeFrame: End of study
Secondary outcomes:
measure: To compare the efficacy in reducing the severity of all hot flashes
timeFrame: Throughout study
measure: To compare the efficacy in elimination of all hot flashes
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Homewood
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Duramed Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Duramed Investigational Site
state: California
city: Fresno
country: United States
facility: Duramed Investigational Site
state: California
city: La Mesa
country: United States
facility: Duramed Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Duramed Investigational Site
state: California
city: Laguna Woods
country: United States
facility: Duramed Investigational Site
state: California
city: Long Beach
country: United States
facility: Duramed Investigational Site
state: California
city: Los Angeles
country: United States
facility: Duramed Investigational Site
state: California
city: San Bernardino
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: Torrance
country: United States
facility: Duramed Investigational Site
state: California
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Middlebury
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Trumbull
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Duramed Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Duramed Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Duramed Investigational Site
state: Florida
city: Ocala
country: United States
facility: Duramed Investigational Site
state: Florida
city: Ocala
country: United States
facility: Duramed Investigational Site
state: Florida
city: Ocala
country: United States
facility: Duramed Investiational Site
state: Florida
city: Plantation
country: United States
facility: Duramed Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Duramed Investigational Site
state: Florida
city: Spring Hill
country: United States
facility: Duramed Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Duramed Investigational site
state: Georgia
city: Coeur d'Alene
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Berwyn
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Kankakee
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Greenwood
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Duramed Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: Duramed Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Greenbelt
country: United States
facility: Duramed Investigational Site
state: Maryland
city: Newton
country: United States
facility: Duramed Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Duramed Investigational Site
state: Massachusetts
city: St. Joseph
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Sartell
country: United States
facility: Duramed Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Duramed Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: Duramed Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Brick
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Edison
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Duramed Investigational Site
state: New York
city: Bayshore
country: United States
facility: Duramed Investigational Site
state: New York
city: Elmont
country: United States
facility: Duramed Investigational Site
state: New York
city: Garden City
country: United States
facility: Duramed Investigational site
state: New York
city: New York
country: United States
facility: Duramed Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Duramed Investigational Site
state: New York
city: Staten Island
country: United States
facility: Duramed Investigational Site
state: New York
city: Williamsville
country: United States
facility: Duramed Investigational Site
state: New York
city: Asheboro
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Duramed Investigational Site
state: North Dakota
city: Canfield
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Canton
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Cincinatti
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Bala Cynwyd
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: State College
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Duramed Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Richmond
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Duramed Investigational Site
state: Wisconsin
city: Kelowna
country: Canada
facility: Duramed Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Duramed Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Duramed Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Duramed Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Duramed Investigational Site
state: British Columbia
city: Saint John
country: Canada
facility: Duramed Investigational Site
state: New Brunswick
city: Kentville
country: Canada
facility: Duramed Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Brantford
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Guelph
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: Duramed Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Duramed Investigational Site
state: Quebec
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References: