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DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Information source: Dexa Medica Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain

Intervention: DLBS1442 (Drug); Mefenamic acid (Drug); DLBS1442 (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Dexa Medica Group

Official(s) and/or principal investigator(s):
Kanadi Sumapraja, SpOG(K), MD, Principal Investigator, Affiliation: Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital

Overall contact:
Kanadi Sumapraja, SpOG(K), MD, Phone: +6221 3928720

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.

Clinical Details

Official title: Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction of intensity (VAS) of composite-pain

Secondary outcome:

Reduction of the intensity of each pain (VAS)

Response rate

Improvement of quality of life

Serum CA-125

IL-6

Number of rescue medication

Pain-free period

Percentage or proportion of subjects who complete the study

ECG

Vital signs

Liver function

Renal function

Routine hematology

Adverse event

Reduction of intensity (VAS) of composite-pain

hs-CRP

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 at minimum, during the menstrual period, i. e. day 1st to day 5th or to the last day (whichever is longer) 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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

- Occurence of at least 3 last sequential menstrual cycles of 21 - 35 days duration

prior to screening

- Adequate liver function: serum ALT <= 2. 5 times upper limit of normal

- Adequate renal function: serum creatinine < 1. 5 times upper limit of normal

- Willingness to postpone surgical therapy for at least 2 months

- Able to take oral medication

- Able and willing to record AE

- Able to comply with the trial protocol

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

- Any other disease state, uncontrolled illnesses, or other chronic diseases, which

judged by the investigator, could interfere with trial participation or trial evaluation

- Known or suspected allergy to similar products

- Subjects with concurrent herbal medicines or food supplements and any treatments

suspected to interfere with the efficacy endpoints

- Enrolled in another interventional study within the last 30 days

Locations and Contacts

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

Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana), Central Jakarta, Jakarta 10430, Indonesia; Not yet recruiting
Kanadi Sumapraja, SpOG(K), MD, Phone: +6221 3928720, Email: kanadisuma@yahoo.com
Budi Wiweko, SpOG(K), MD, Phone: +6221 39831098, Email: wiwekobudi@yahoo.co.id
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
Shanty Olivia, SpOG, MD, Sub-Investigator
Mila Maidarti, SpOG, MD, Sub-Investigator
Additional Information

Starting date: May 2015
Last updated: April 12, 2015

Page last updated: August 23, 2015

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