NCT04736186

Prevention and Treatment of Pyrrolitinib-associated Diarrhea

Prevention and Treatment of Pyrrolitinib-associated Diarrhea: a Prospective, Multicenter, Open-label Clinical Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study can only be formally carried out with the written approval of the ethics committee. Investigators regularly submit annual research reports to the ethics committee. Investigators will inform the ethics committee in writing when the study is discontinued and / or completed. All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation. In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Loperamide	Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)
DRUG	Loperamide and golden bifid	Patients with secondary prevention will be randomly assigned to B：Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)+golden bifid 2 g t.i.d.
DRUG	Loperamide and montmorillonite powder	Patients with secondary prevention will be randomly assigned to D：Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)+montmorillonite powder 3 g t.i.d.

Timeline

• Start date: 2020-05-16
• Primary completion: 2022-10-31
• Completion: 2023-04-30
• First posted: 2021-02-03
• Last updated: 2021-02-03

Locations

1 site across 1 country: China