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DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Dexa Medica Group
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01942122
First received: September 10, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Patients Suspected Endometriosis
Moderate or Severe Pain on VAS
Willing to Postpone the Surgical Therapy
Drug: DLBS1442
Drug: Mefenamic acid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:
  • Reduction of intensity (VAS) of composite-pain [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 4, week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4, week 8 ] [ Designated as safety issue: No ]
    Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.

  • Serum CA-125 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Reduction in serum CA-125 level.

  • IL-6 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Change of IL-6

  • Number of rescue medication [ Time Frame: During the course of the study ] [ Designated as safety issue: No ]
    Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.

  • Pain-free period [ Time Frame: During the course of the study ] [ Designated as safety issue: No ]
    Time to the first day on which subjects take rescue medication.

  • Percentage or proportion of subjects who complete the study [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage or proportion of subjects who complete the study (2 cycles).

  • ECG [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    Electrocardiography.

  • Vital signs [ Time Frame: Week 4, week 8 ] [ Designated as safety issue: Yes ]
    Vital signs measured include: blood pressure, heart rate, respiratory rate.

  • Liver function [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).

  • Renal function [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).

  • Routine hematology [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.

  • Adverse event [ Time Frame: During the course of the study ] [ Designated as safety issue: Yes ]
    Adverse event will be observed and managed along the study course.

  • Reduction of intensity (VAS) of composite-pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Change in serum hs-CRP.


Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DLBS1442, 3 x 100 mg
DLBS1442 capsules 3x100 mg daily, taken every day along the study period
Drug: DLBS1442
Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily or DLBS1442 at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
Other Name: Dismeno
Experimental: DLBS1442, 3 x 200 mg
DLBS1442 capsules 3x200 mg daily, taken every day along the study period
Drug: DLBS1442
Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily or DLBS1442 at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
Other Name: Dismeno
Active Comparator: Mefenamic acid
Mefenamic acid tablets 3 x 500 mg daily, only 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.
Drug: Mefenamic acid
Control will be mefenamic acid 500 mg tablets, administered 3 times daily for 5 days at minimum, during the menstrual period, i.e. day 1st to day 5th or to the last day (whichever is longer) of the menstrual period. The drug will be given within the 8 weeks of study period (2 menstrual cycles).
Other Name: Pondex Forte

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942122

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

Locations
Indonesia
Yasmin Clinic, Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital Not yet recruiting
Central Jakarta, Jakarta, Indonesia, 10430
Contact: Kanadi Sumapraja, SpOG(K), MD    +6221 3928720    kanadisuma@yahoo.com   
Contact: Budi Wiweko, SpOG(K), MD    +6221 39831098    wiwekobudi@yahoo.co.id   
Sub-Investigator: 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         
Sponsors and Collaborators
Dexa Medica Group
Investigators
Principal Investigator: Kanadi Sumapraja, SpOG(K), MD Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital
  More Information

No publications provided

Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01942122     History of Changes
Other Study ID Numbers: DLBS1442-0212
Study First Received: September 10, 2013
Last Updated: October 7, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
DLBS1442
Endometriosis
pain
VAS
EHP-30

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Mefenamic Acid
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014