Clinical trial NCT01942122: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endometrioma
Visual Analogue Pain Scale: Moderate or Severe Pain
Keywords: DLBS1442
Endometriosis
Pain
Visual Analogue Scale
Endometriosis Health Profile (EHP-30TM)
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of intensity (VAS) of composite-pain
timeFrame: Week 8
Secondary outcomes:
measure: Reduction of the intensity of each pain (VAS)
timeFrame: Week 4, week 8
measure: Response rate
timeFrame: Week 8
measure: Improvement of quality of life
timeFrame: Week 4, week 8
measure: Serum CA-125
timeFrame: Week 8
measure: IL-6
timeFrame: Week 8
measure: Number of rescue medication
timeFrame: During the course of the study
measure: Pain-free period
timeFrame: During the course of the study
measure: Percentage or proportion of subjects who complete the study
timeFrame: Week 8
measure: ECG
timeFrame: Week 8
measure: Vital signs
timeFrame: Week 4, week 8
measure: Liver function
timeFrame: Week 8
measure: Renal function
timeFrame: Week 8
measure: Routine hematology
timeFrame: Week 8
measure: Adverse event
timeFrame: During the course of the study
measure: Reduction of intensity (VAS) of composite-pain
timeFrame: 4 weeks
measure: hs-CRP
timeFrame: Week 8
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)
state: Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Department of Obstetrics and Gynecology, RSUP Persahabatan
state: Jakarta
city: Jakarta
country: Indonesia
facility: Department of Obstetrics and Gynecology RSUP Fatmawati
Study officials:
affiliation: Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital
name: Kanadi Sumapraja, SpOG(K), MD
role: PRINCIPAL_INVESTIGATOR
References: