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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00196339
First received: September 12, 2005
Last updated: August 27, 2013
Last verified: August 2012

September 12, 2005
August 27, 2013
June 2005
January 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • * To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
  • * To evaluate the safety compared to placebo
  • * Identify the lowest effective dose.
Complete list of historical versions of study NCT00196339 on ClinicalTrials.gov Archive Site
  • 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 ]
  • * To compare the efficacy in reducing the severity of all hot flashes
  • * To compare the efficacy in elimination of all hot flashes
Not Provided
Not Provided
 
A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: DR-2031a
    1 tablet daily
  • Drug: DR-2031b
    1 tablet daily
  • Drug: DR-2031c
    1 tablet daily
  • Drug: Placebo
    1 tablet daily
  • Experimental: cyproterone acetate 5 mg
    Intervention: Drug: DR-2031a
  • Experimental: cyproterone acetate 15 mg
    Intervention: Drug: DR-2031b
  • Experimental: cyproterone acetate 25 mg
    Intervention: Drug: DR-2031c
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00196339
DR-PCA-201
Yes
Teva Pharmaceutical Industries ( Duramed Research )
Duramed Research
Not Provided
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
Teva Pharmaceutical Industries
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP