drugset / Trial / NCT04736186
Prevention and Treatment of Pyrrolitinib-associated Diarrhea
RandomizedParallel-groupOpen-labelPrevention
Summary
In this study, patients taking pyrrolitinib alone or combined with pyrrolitinib were recruited (170 cases of secondary prevention and 300 cases of non-secondary prevention). Non-secondary prevention: Explore the recovery time of oral loperamide 4mg T.I.D. for pyrrolitinib induced diarrhea of 1-2 degrees. Secondary prevention: To explore the incidence of grade 3 and above diarrhea during c1D1-C1D22 in patients with oral loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21).
Timeline
- Start
- 2020-05-16
- Primary completion
- 2022-10-31
- Completion
- 2023-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Loperamide | Small molecule | 4 mg | Oral |
| Subject | golden bifid | Unknown | 2 g | — |
| Subject | montmorillonite | Other / unclassified | 3 g | — |