DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

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.

Study Overview

• Status: Completed
• Conditions: Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain
• Intervention / Treatment: Drug: DLBS1442 100; Drug: DLBS1442 200; Drug: Mefenamic acid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Department of Obstetrics and Gynecology RSUP Fatmawati
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)
    • Jakarta Pusat, Jakarta, Indonesia
      • Department of Obstetrics and Gynecology, RSUP Persahabatan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLBS1442 100; DLBS1442 capsules 3x100 mg daily, taken every day along the study period	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).; Other Names: Dismeno 100
Experimental: DLBS1442 200; DLBS1442 capsules 3x200 mg daily, taken every day along the study period	Drug: 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).; Other Names: Dismeno 200
Active Comparator: Mefenamic acid; 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.	Drug: 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).; Other Names: Pondex Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Improvement of quality of life	Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.	Week 4, week 8
Serum CA-125	Reduction in serum CA-125 level.	Week 8
IL-6	Change of IL-6	Week 8
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
Pain-free period	Time to the first day on which subjects take rescue medication.	During the course of the study
Percentage or proportion of subjects who complete the study	Percentage or proportion of subjects who complete the study (2 cycles).	Week 8
ECG	Electrocardiography.	Week 8
Vital signs	Vital signs measured include: blood pressure, heart rate, respiratory rate.	Week 4, week 8
Liver function	Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).	Week 8
Renal function	Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).	Week 8
Routine hematology	Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.	Week 8
Adverse event	Adverse event will be observed and managed along the study course.	During the course of the study
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
hs-CRP	Change in serum hs-CRP.	Week 8

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Kanadi Sumapraja, SpOG(K), MD, Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Endometriosis; Visual Analogue Scale; DLBS1442; Endometriosis Health Profile (EHP-30TM)
• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Mefenamic Acid
• Other Study ID Numbers: DLBS1442-0212