drugset / Trial / NCT01942122

DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

NCT01942122

Phase 2/3 Completed 60 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-10
Primary completion
2021-02
Completion
2021-04

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS1442 Unknown 100 mg
Subject DLBS1442 Unknown 200 mg
Comparator Mefenamic acid Small molecule 500 mg

Indications