DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Endometrioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942122
• Other study ID #: DLBS1442-0212
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Visual Analogue Pain Scale: Moderate or Severe Pain

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