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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01942122
Other study ID # DLBS1442-0212
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2015
Est. completion date April 2021

Study information

Verified date January 2022
Source Dexa Medica Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.


Description:

There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1442 at a dose of 3 x 100 mg daily, or 2) DLBS1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x 500 mg daily. DLBS1442 will be taken every day along the study period (8 weeks), while mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. Study treatment will be given at a standardized starting point for all subjects, i.e. on the first day of their respective menstrual periods. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and every 4-week interval throughout the study period.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Signed informed consent before any trial related activities - Female of 18 - 50 years of age - Subjects suspected with cystic endometriosis or adenomyosis confirmed by transvaginal ultrasonography (or transrectal ultrasonography for unmarried subjects) - Presence of moderate or severe pain as shown by VAS score of at least 4 on at least one of the following pain: menstrual pain (dysmenorrhea), dyspareunia, non-menstrual pelvic pain, dysuria, dyschezia - Occurrence of at least 3 last sequential menstrual cycles of 21 - 35 days duration prior to screening Exclusion Criteria: - Pregnancy - Patients with infertility who are willing to be pregnant - Using hormonal contraception or other forms of hormonal therapy within the last 30 days - Being under therapy with systemic corticosteroids on a chronic or regular basis within the last 90 days - History or presence of suspected malignancy abnormalities - History of surgical treatment for endometriosis within 3 months prior to screening - History of hysterectomy or oophorectomy - Presence of clinical signs of sexually transmitted disease - Presence of unexplained uterine or cervical bleeding - Impaired liver function: serum ALT > 2.5 times upper limit of normal - Impaired renal function: serum creatinine >= 1.5 times upper limit of normal - Known or suspected allergy to similar products

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DLBS1442 100
Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
Mefenamic acid
Control will be mefenamic acid 500 mg tablets, administered 3 times daily for 5 days during the menstrual period, i.e. day 1st to day 5th of the menstrual period. The drug will be given within the 8 weeks of study period (2 menstrual cycles).
DLBS1442 200
Study treatment will be DLBS1442 capsules at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).

Locations

Country Name City State
Indonesia Department of Obstetrics and Gynecology RSUP Fatmawati Jakarta
Indonesia Department of Obstetrics and Gynecology, RSUP Persahabatan Jakarta Pusat Jakarta
Indonesia Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana) Jakarta Pusat Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of intensity (VAS) of composite-pain Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS). Week 8
Secondary Reduction of the intensity of each pain (VAS) Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS). Week 4, week 8
Secondary Response rate Response rate is defined as percentage of subjects at the end of study experiencing a reduction of VAS score of >= 3 or >= 30% as compared to baseline, in each of the composite pain found at baseline (i.e. dysmenorrhea, dyspareunia, non-menstrual pelvic pain, dysuria, or dyschezia). Week 8
Secondary Improvement of quality of life Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score. Week 4, week 8
Secondary Serum CA-125 Reduction in serum CA-125 level. Week 8
Secondary IL-6 Change of IL-6 Week 8
Secondary Number of rescue medication Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study. During the course of the study
Secondary Pain-free period Time to the first day on which subjects take rescue medication. During the course of the study
Secondary Percentage or proportion of subjects who complete the study Percentage or proportion of subjects who complete the study (2 cycles). Week 8
Secondary ECG Electrocardiography. Week 8
Secondary Vital signs Vital signs measured include: blood pressure, heart rate, respiratory rate. Week 4, week 8
Secondary Liver function Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP). Week 8
Secondary Renal function Renal function measured includes: serum creatinine and blood urea nitrogen (BUN). Week 8
Secondary Routine hematology Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count. Week 8
Secondary Adverse event Adverse event will be observed and managed along the study course. During the course of the study
Secondary Reduction of intensity (VAS) of composite-pain Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS). 4 weeks
Secondary hs-CRP Change in serum hs-CRP. Week 8
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