Effect of KYG0395 on Primary Dysmenorrhea
This study is currently recruiting participants.
Verified November 2012 by Jiangsu Kanion Pharmaceutical Co.,Ltd
Sponsor:
Jiangsu Kanion Pharmaceutical Co.,Ltd
Information provided by (Responsible Party):
Jiangsu Kanion Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01588236
First received: April 26, 2012
Last updated: January 22, 2013
Last verified: November 2012
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Purpose
The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Dysmenorrhea |
Drug: KYG0395 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Further Assess the Efficacy, Safety and Dose Response of KYG0395 in the Treatment of Primary Dysmenorrhea |
Further study details as provided by Jiangsu Kanion Pharmaceutical Co.,Ltd:
Primary Outcome Measures:
- The maximum dysmenorrheic pain visual analog scale (VAS) score at the end of 3 treatment cycles compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- The number of days of dysmenorrheic pain per cycle at the end of 3 treatment cycles compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- The maximum dysmenorrheic pain VAS score at the end of a 3-cycle follow-up period compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- The number of days of dysmenorrheic pain per cycle at the end of a 3-cycle follow-up period compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average daily dysmenorrheic pain VAS score in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Rescue medication consumption in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Accompanying symptoms in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Severity of menstrual bleeding in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Subject's overall satisfaction at the end of the 3 treatment cycles and at the end of the 3-cycle follow-up period [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Responder rate in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 213 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: KYG0395 (high dose group) |
Drug: KYG0395
3 KYG0395 capsules tid (morning, midday, and evening)
|
| Experimental: KYG0395 (lower dose group) |
Drug: KYG0395
3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
| Placebo Comparator: placebo |
Drug: placebo
3 capsules of placebo tid (morning, midday, and evening)
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Otherwise healthy female subjects (age between 18 and 35, BMI equals or less than 32),with primary dysmenorrhea for at least 3 consecutive menstrual cycles prior to the study (prior to the start of the baseline cycles) and with VAS score > 70 for the maximum dysmenorrheic pain or VAS score > 40 for the average daily dysmenorrheic pain of the last menstrual cycle.
Exclusion Criteria:
- Known or suspected to have secondary dysmenorrhea due to pelvic inflammation, endometriosis, uterine myomata, ovarian pathological changes, or other pelvic diseases.
- Pregnant or trying to conceive during the study. Recent delivery, abortion, or lactation within 3 menstrual cycles before the start of treatment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588236
Contacts
| Contact: Andrew Jiang | 973-850-5298 | andrew.jiang@aleonpharma.com |
Locations
| United States, Arizona | |
| Women's Health Research | Recruiting |
| Phoenix, Arizona, United States, 85015 | |
| United States, Arkansas | |
| Lynn Institute of the Ozarks | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Georgia | |
| Atlanta Women's Research Institute, Inc. | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| United States, Idaho | |
| Women's Healthcare Associates dba Rosemark WomenCare Specialists | Recruiting |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Chicago Research Center, Inc. | Recruiting |
| Chicago, Illinois, United States, 60634 | |
| United States, Massachusetts | |
| Genesis Clinical Research | Recruiting |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Montana | |
| Montana Medical Research | Recruiting |
| Missoula, Montana, United States, 59808 | |
| United States, New Jersey | |
| Lawrence OB GYN Associates | Recruiting |
| Lawrenceville, New Jersey, United States, 08648 | |
| United States, New York | |
| Suffolk OB-GYN | Recruiting |
| Port Jefferson, New York, United States, 11777 | |
| United States, South Carolina | |
| SC Clinical Research Center, LLC | Recruiting |
| Columbia, South Carolina, United States, 29201 | |
| United States, Tennessee | |
| Dial Research Associates, Inc. | Recruiting |
| Nashville, Tennessee, United States, 37215 | |
| United States, Texas | |
| Benchmark Research | Recruiting |
| Austin, Texas, United States, 78705 | |
| Advanced Research Associates | Recruiting |
| Corpus Christi, Texas, United States, 78414 | |
| Advances in Health | Recruiting |
| Houston, Texas, United States, 77030 | |
| Clinical Trials of Texas, Inc. | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Women's Clinical Research Center | Recruiting |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
Jiangsu Kanion Pharmaceutical Co.,Ltd
More Information
No publications provided
| Responsible Party: | Jiangsu Kanion Pharmaceutical Co.,Ltd |
| ClinicalTrials.gov Identifier: | NCT01588236 History of Changes |
| Other Study ID Numbers: | GF-2011-001 |
| Study First Received: | April 26, 2012 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dysmenorrhea Menstruation Disturbances Pathologic Processes |
Pelvic Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013