Endometrioma, Visual Analogue Pain Scale: Moderate or Severe Pain
Conditions
Keywords
DLBS1442, Endometriosis, Pain, Visual Analogue Scale, Endometriosis Health Profile (EHP-30TM)
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.
Interventions
DRUGDLBS1442 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).
DRUGMefenamic 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).
DRUGDLBS1442 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).
Sponsors
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of intensity (VAS) of composite-pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 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). |
| Improvement of quality of life | Week 4, week 8 | Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score. |
| Serum CA-125 | Week 8 | Reduction in serum CA-125 level. |
| IL-6 | Week 8 | Change of IL-6 |
| Number of rescue medication | 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. |
| Pain-free period | During the course of the study | Time to the first day on which subjects take rescue medication. |
| Percentage or proportion of subjects who complete the study | Week 8 | Percentage or proportion of subjects who complete the study (2 cycles). |
| Reduction of the intensity of each pain (VAS) | 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). |
| Vital signs | Week 4, week 8 | Vital signs measured include: blood pressure, heart rate, respiratory rate. |
| Liver function | Week 8 | Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP). |
| Renal function | Week 8 | Renal function measured includes: serum creatinine and blood urea nitrogen (BUN). |
| Routine hematology | Week 8 | Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count. |
| Adverse event | During the course of the study | Adverse event will be observed and managed along the study course. |
| Reduction of intensity (VAS) of composite-pain | 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). |
| hs-CRP | Week 8 | Change in serum hs-CRP. |
| ECG | Week 8 | Electrocardiography. |
Countries
Indonesia
Outcome results
None listed