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Prevention and Treatment of Pyrrolitinib-associated Diarrhea

NCT04736186 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2021-02-03

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-16
Primary Completion
2022-10-31
Completion
2023-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04736186 on ClinicalTrials.gov