DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

• ClinicalTrials.gov Identifier: NCT01942122
• Recruitment Status: Recruiting
• First Posted: September 13, 2013
• Last Update Posted: January 7, 2021
• Sponsor: Dexa Medica Group
• Information provided by (Responsible Party): Dexa Medica Group

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain	Drug: DLBS1442 100; Drug: Mefenamic acid; Drug: DLBS1442 200	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
• Study Start Date: October 2015
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: June 2021

Arms and Interventions

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 Name: 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 Name: 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 Name: Pondex Forte

Outcome Measures

Primary Outcome Measures :

1. Reduction of intensity (VAS) of composite-pain [ Time Frame: Week 8 ]
   Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).

Secondary Outcome Measures :

1. Reduction of the intensity of each pain (VAS) [ Time Frame: Week 4, week 8 ]
   Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
2. Response rate [ Time Frame: Week 8 ]
   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).
3. Improvement of quality of life [ Time Frame: Week 4, week 8 ]
   Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.
4. Serum CA-125 [ Time Frame: Week 8 ]
   Reduction in serum CA-125 level.
5. IL-6 [ Time Frame: Week 8 ]
   Change of IL-6
6. Number of rescue medication [ Time Frame: During the course of the study ]
   Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.
7. Pain-free period [ Time Frame: During the course of the study ]
   Time to the first day on which subjects take rescue medication.
8. Percentage or proportion of subjects who complete the study [ Time Frame: Week 8 ]
   Percentage or proportion of subjects who complete the study (2 cycles).
9. ECG [ Time Frame: Week 8 ]
   Electrocardiography.
10. Vital signs [ Time Frame: Week 4, week 8 ]
    Vital signs measured include: blood pressure, heart rate, respiratory rate.
11. Liver function [ Time Frame: Week 8 ]
    Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).
12. Renal function [ Time Frame: Week 8 ]
    Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).
13. Routine hematology [ Time Frame: Week 8 ]
    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
14. Adverse event [ Time Frame: During the course of the study ]
    Adverse event will be observed and managed along the study course.
15. Reduction of intensity (VAS) of composite-pain [ Time Frame: 4 weeks ]
    Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
16. hs-CRP [ Time Frame: Week 8 ]
    Change in serum hs-CRP.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Kanadi Sumapraja, SpOG(K), MD; +6221 3928720

Locations

Indonesia

Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana); Recruiting

Jakarta Pusat, Jakarta, Indonesia, 10430

Contact: Kanadi Sumapraja, SpOG(K), MD +6221 3928720 kanadisuma@yahoo.com

Contact: Budi Wiweko, SpOG(K), MD +6221 39831098 wiwekobudi@yahoo.co.id

Sub-Investigator: R. Muharam, SpOG(K), MD

Sub-Investigator: Andon Hestiantoro, SpOG(K), MD

Sub-Investigator: Budi Wiweko, SpOG(K), MD

Sub-Investigator: Herbert Situmorang, SpOG(K), MD

Sub-Investigator: Gita Pratama, SpOG(K), MD

Sub-Investigator: Achmad K Harzif, SpOG, MD

Sub-Investigator: Mila Maidarti, SpOG, MD

Sub-Investigator: Vita Silvana, SpOG, MD

Department of Obstetrics and Gynecology, RSUP Persahabatan; Recruiting

Jakarta Pusat, Jakarta, Indonesia

Contact: Botefilia, SpOG (K), MD +62214891708 botefilia@yahoo.com

Principal Investigator: Botefilia, SpOG (K), MD

Sub-Investigator: Zakia, SpOG, MD

Sub-Investigator: Devi Marischa, SpOG, MD

Department of Obstetrics and Gynecology RSUP Fatmawati; Completed

Jakarta, Indonesia

Sponsors and Collaborators

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

More Information

• Responsible Party: Dexa Medica Group
• ClinicalTrials.gov Identifier: NCT01942122
• Other Study ID Numbers: DLBS1442-0212
• First Posted: September 13, 2013
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Keywords provided by Dexa Medica Group:

DLBS1442; Endometriosis; Pain; Visual Analogue Scale; Endometriosis Health Profile (EHP-30TM)

Additional relevant MeSH terms:

Endometriosis; Mefenamic Acid; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action