NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031220181

Registered date:05/07/2022

A clinical study of KLH-2109 in uterine fibroids patient with menorrhagia and pain

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedUterine fibroid
Date of first enrollment23/06/2022
Target sample size78
Countries of recruitment
Study typeInterventional
Intervention(s)Oral administration of KLH-2109 or placebo

Outcome(s)

Primary Outcome- Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration - Proportion of subjects with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
Secondary Outcome- Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration - Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration - Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days - Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration - Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days - Average NRS score every 28 days for pain symptoms - Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration - Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days - Incidence of adverse events and adverse drug reactions - Changes and fluctuations from baseline in laboratory tests (hematological, biochemical and urinalysis) - Changes and fluctuations from baseline in vital signs (blood pressure, pulse rate and body temperature) - Changes and fluctuations from baseline in body weight - Changes and fluctuations from baseline in parameters of 12-lead ECG

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria- Japanese uterine fibroid patients - Premenopausal female patient over 20 years old - Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions: - Larger than a certain standard - No calcification - Not receiving surgical treatment - Patients with a normal menstrual cycle - Patients diagnosed with menorrhagia - Patients with pain symptoms associated with uterine fibroids
Exclude criteria- Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia) - Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis - Patients with undiagnosed abnormal genital bleeding

Related Information

Contact

Public contact
Name Yoshitaka Shimizu
Address 3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan Tokyo Japan 112-0002
Telephone +81-120-007-622
E-mail rinsyousiken@pharm.kissei.co.jp
Affiliation Kissei Pharmaceutical Co., Ltd.
Scientific contact
Name Yoshitaka Shimizu
Address 3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan Tokyo Japan 112-0002
Telephone +81-120-007-622
E-mail rinsyousiken@pharm.kissei.co.jp
Affiliation Kissei Pharmaceutical Co., Ltd.