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

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00196339

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: DR-2031a Drug: DR-2031b Drug: DR-2031c Drug: Placebo	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Duramed Research:

Primary Outcome Measures:

To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
To evaluate the safety compared to placebo [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Identify the lowest effective dose. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the efficacy in reducing the severity of all hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
To compare the efficacy in elimination of all hot flashes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	315
Study Start Date:	June 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DR-2031a 1 tablet daily
2: Experimental	Drug: DR-2031b 1 tablet daily
3: Experimental	Drug: DR-2031c 1 tablet daily
4: Placebo Comparator	Drug: Placebo 1 tablet daily

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196339

Show 119 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

MedLine Plus - Prostate Cancer This link exits the ClinicalTrials.gov site

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	PCA-201
Study First Received:	September 12, 2005
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00196339
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

prostate cancer
hot flashes
hot flushes
vasomotor symptoms

Study placed in the following topic categories:

Signs and Symptoms
Prostatic Diseases
Genital Neoplasms, Male
Hot Flashes

Flushing
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009