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Trial record 2 of 9 for:    klh | First posted from 01/01/2011 to 02/01/2012

A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)

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: NCT01395940
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : October 30, 2013
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 18, 2011
Last Update Posted Date October 30, 2013
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2011)
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 Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
Official Title  ICMJE A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)
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: KLH-2109, lower dose
    Intervention: Drug: KLH-2109
  • Experimental: 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
Estimated Enrollment  ICMJE
 (submitted: July 14, 2011)
20
Original Estimated 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 NCT01395940
Other Study ID Numbers  ICMJE KLH1201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Katsumi Hontani Kissei Pharmaceutical Co., Ltd.
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date October 2013

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