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Trial record 1 of 2 for:    klh | First posted from 06/01/2012 to 08/16/2012
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A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01629420
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 25, 2012
First Posted Date  ICMJE June 27, 2012
Last Update Posted Date May 30, 2014
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
The severity score of the pelvic pain [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
Official Title  ICMJE A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)
Brief Summary The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE Drug: KLH-2109
Study Arms  ICMJE
  • Experimental: Drug:KLH-2109 lower dose
    Intervention: Drug: KLH-2109
  • Experimental: Drug:KLH-2109 higher dose
    Intervention: Drug: KLH-2109
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 25, 2012)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients with endometriosis

Exclusion Criteria:

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01629420
Other Study ID Numbers  ICMJE KLH1203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kissei Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date May 2014

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