Overview

Conditions endometrioma, visual analogue pain scale: moderate or severe pain
Treatments dlbs1442 100, mefenamic acid, dlbs1442 200
Phase phase 2/phase 3
Sponsor Dexa Medica Group
Start date October 2015
End date November 2017
Trial size 60 participants
Trial identifier NCT01942122, DLBS1442-0212

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Indonesia

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
DLBS1442 capsules 3x100 mg daily, taken every day along the study period
dlbs1442 100 Dismeno 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).
(Experimental)
DLBS1442 capsules 3x200 mg daily, taken every day along the study period
dlbs1442 200 Dismeno 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).
(Active Comparator)
Mefenamic acid tablets 3 x 500 mg daily, only taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period.
mefenamic acid Pondex Forte
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).

Primary Outcomes

Measure
Reduction of intensity (VAS) of composite-pain
time frame: Week 8

Secondary Outcomes

Measure
Reduction of the intensity of each pain (VAS)
time frame: Week 4, week 8
Response rate
time frame: Week 8
Improvement of quality of life
time frame: Week 4, week 8
Serum CA-125
time frame: Week 8
IL-6
time frame: Week 8
Number of rescue medication
time frame: During the course of the study
Pain-free period
time frame: During the course of the study
Percentage or proportion of subjects who complete the study
time frame: Week 8
ECG
time frame: Week 8
Vital signs
time frame: Week 4, week 8
Liver function
time frame: Week 8
Renal function
time frame: Week 8
Routine hematology
time frame: Week 8
Adverse event
time frame: During the course of the study
Reduction of intensity (VAS) of composite-pain
time frame: 4 weeks
hs-CRP
time frame: Week 8

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
Principal investigator Kanadi Sumapraja, SpOG(K), MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Dexa Medica Group.