Treatment of Primary Menstrual Pain With Kanion Capsule

This study has been completed.

Sponsor:

Information provided by:

Lianyungang Kanion Group, Ltd.

ClinicalTrials.gov Identifier:

NCT00523146

First received: August 29, 2007

Last updated: February 2, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2007

Last Updated Date

February 2, 2010

Start Date ^ICMJE

April 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain reduction [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00523146 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

accompanying symptoms improvement [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Primary Menstrual Pain With Kanion Capsule

Official Title ^ICMJE

Treatment of Primary Dysmenorrhea With Kanion Capsule (GF) A Randomized, Double-blind, Placebo-controlled, Repeated-Dose and Multi-Center Clinical Phase II Trial

Brief Summary

The objectives of this clinical trial are:

To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;
To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Primary Dysmenorrhea

Intervention ^ICMJE

Drug: Kanion Capsule

Study Arm (s)

Not Provided

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

Not Provided

Completion Date

February 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

primary dysmenorrhea

Exclusion Criteria:

secondary dysmenorrhea

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00523146

Other Study ID Numbers ^ICMJE

GF-2006-001

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Lianyungang Kanion Group, Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jun Shao, Ph.D.

Biokey Inc.

Information Provided By

Lianyungang Kanion Group, Ltd.

Verification Date

February 2010

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

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