drugset / Trial / NCT01942122
DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DLBS1442 | Unknown | 100 mg | — |
| Subject | DLBS1442 | Unknown | 200 mg | — |
| Comparator | Mefenamic acid | Small molecule | 500 mg | — |