Back to resultsDLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
Primary Purpose
Endometrioma, Visual Analogue Pain Scale: Moderate or Severe Pain
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
DLBS1442 100
Mefenamic acid
DLBS1442 200
Sponsored by
About this trial
This is an interventional treatment trial for Endometrioma focused on measuring DLBS1442, Endometriosis, Pain, Visual Analogue Scale, Endometriosis Health Profile (EHP-30TM)
Eligibility 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
Sites / Locations
- Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)
- Department of Obstetrics and Gynecology, RSUP Persahabatan
- Department of Obstetrics and Gynecology RSUP Fatmawati
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
DLBS1442 100
DLBS1442 200
Mefenamic acid
Arm Description
DLBS1442 capsules 3x100 mg daily, taken every day along the study period
DLBS1442 capsules 3x200 mg daily, taken every day along the study period
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
Improvement of quality of life
Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.
Serum CA-125
Reduction in serum CA-125 level.
IL-6
Change of IL-6
Number of rescue medication
Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.
Pain-free period
Time to the first day on which subjects take rescue medication.
Percentage or proportion of subjects who complete the study
Percentage or proportion of subjects who complete the study (2 cycles).
ECG
Electrocardiography.
Vital signs
Vital signs measured include: blood pressure, heart rate, respiratory rate.
Liver function
Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).
Renal function
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).
Routine hematology
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Adverse event
Adverse event will be observed and managed along the study course.
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).
hs-CRP
Change in serum hs-CRP.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01942122
Brief Title
DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
Official Title
Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
April 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma, Visual Analogue Pain Scale: Moderate or Severe Pain
Keywords
DLBS1442, Endometriosis, Pain, Visual Analogue Scale, Endometriosis Health Profile (EHP-30TM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DLBS1442 100
Arm Type
Experimental
Arm Description
DLBS1442 capsules 3x100 mg daily, taken every day along the study period
Arm Title
DLBS1442 200
Arm Type
Experimental
Arm Description
DLBS1442 capsules 3x200 mg daily, taken every day along the study period
Arm Title
Mefenamic acid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DLBS1442 100
Other Intervention Name(s)
Dismeno 100
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Mefenamic acid
Other Intervention Name(s)
Pondex Forte
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
DLBS1442 200
Other Intervention Name(s)
Dismeno 200
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction of intensity (VAS) of composite-pain
Description
Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Reduction of the intensity of each pain (VAS)
Description
Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Time Frame
Week 4, week 8
Title
Response rate
Description
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).
Time Frame
Week 8
Title
Improvement of quality of life
Description
Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.
Time Frame
Week 4, week 8
Title
Serum CA-125
Description
Reduction in serum CA-125 level.
Time Frame
Week 8
Title
IL-6
Description
Change of IL-6
Time Frame
Week 8
Title
Number of rescue medication
Description
Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.
Time Frame
During the course of the study
Title
Pain-free period
Description
Time to the first day on which subjects take rescue medication.
Time Frame
During the course of the study
Title
Percentage or proportion of subjects who complete the study
Description
Percentage or proportion of subjects who complete the study (2 cycles).
Time Frame
Week 8
Title
ECG
Description
Electrocardiography.
Time Frame
Week 8
Title
Vital signs
Description
Vital signs measured include: blood pressure, heart rate, respiratory rate.
Time Frame
Week 4, week 8
Title
Liver function
Description
Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).
Time Frame
Week 8
Title
Renal function
Description
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).
Time Frame
Week 8
Title
Routine hematology
Description
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Time Frame
Week 8
Title
Adverse event
Description
Adverse event will be observed and managed along the study course.
Time Frame
During the course of the study
Title
Reduction of intensity (VAS) of composite-pain
Description
Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Time Frame
4 weeks
Title
hs-CRP
Description
Change in serum hs-CRP.
Time Frame
Week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanadi Sumapraja, SpOG(K), MD
Organizational Affiliation
Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Department of Obstetrics and Gynecology, RSUP Persahabatan
City
Jakarta Pusat
State/Province
Jakarta
Country
Indonesia
Facility Name
Department of Obstetrics and Gynecology RSUP Fatmawati
City
Jakarta
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
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