Prevention and Treatment of Pyrrolitinib-associated Diarrhea: a Prospective, Multicenter, Open-label Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- time from the first day of treatment until diarrhea returns to level 0 or baseline during the first day of treatment to the 22nd day of treatment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following two situations:
- •A) Plan to take pyrrolitinib for ≥21 days; B) Third-degree diarrhea or second-degree diarrhea with complications after taking pyrrolitinib at present, plan to take pyrrolitinib for ≥21 days;
- •Age ≥18 years;
- •ECOG PS 0-2;
- •Life expectancy ≥6 months;
- •Participate in this study voluntarily, sign informed consent, have good compliance and are willing to cooperate with the follow-up.
排除标准
- •May be allergic to pyrrolitinib or excipients;
- •There are many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting;
- •Patients with biliary obstruction;
- •Participate in other diarrhea-related clinical trials;
- •Pregnant and lactating women, fertile women who tested positive in the baseline pregnancy test, or women of childbearing age who were unwilling to use effective contraception during the whole trial period;
- •Concomitant diseases (including but not limited to severe hypertension beyond the control of drugs, severe diabetes, etc.) that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study; The investigator concluded that the patient was not eligible for any of the other conditions in the study.
研究组 & 干预措施
Loperamide
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21)
干预措施: Loperamide (Drug)
Loperamide and gold bifid
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D.
干预措施: Loperamide (Drug)
Loperamide and gold bifid
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + gold bifid2g T.I.D.
干预措施: Loperamide and golden bifid (Drug)
Loperamide and Montmorillonite SAN
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D.
干预措施: Loperamide (Drug)
Loperamide and Montmorillonite SAN
Loperamide 4 mg, T.I.D. (D1-7) →4 mg, B.I.D. (D8-21) + Montmorillonite SAN 3 g, T.I.D.
干预措施: Loperamide and montmorillonite powder (Drug)
结局指标
主要结局
time from the first day of treatment until diarrhea returns to level 0 or baseline during the first day of treatment to the 22nd day of treatment
时间窗: From the first day of treatment to the 22nd day of treatment(about 21 days)
Non-secondary prevention
The proportion of 3/4 degree diarrhea in group A From the first day of treatment to the 22nd day of treatment
时间窗: From the first day of treatment to the 22nd day of treatment(about 21 days)
Secondary prevention
次要结局
- 3/4 degree incidence of diarrhea(From the first day of treatment to the 22nd day of treatment(about 21 days))
- Loperamide combined program, diarrhea recovery to level 0 or baseline time(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The accumulated time of diarrhea during the follow-up period(From the first day of treatment to the 22nd day of treatment(about 21 days))
- Time of first occurrence of diarrhea(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The incidence rate of all degrees of diarrhea during the follow-up period(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The incidence of constipation of degree 2 or above during the follow-up period(From the first day of treatment to the 22nd day of treatment(about 21 days))
- Other AE/SAE during the follow-up period(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The proportion of cases with 3/4 degree diarrhea(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The proportion of incidences of 3/4 degree diarrhea during follow-up(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The time of the first diarrhea attack during the follow-up period(From the first day of treatment to the 22nd day of treatment(about 21 days))
- The cumulative duration of diarrhea during the follow-up period(From the first day of treatment to the 22nd day of treatment(about 21 days))
- Proportion of subjects with delayed or reduced doses of pyrrolitinib due to diarrhea(From the first day of treatment to the 22nd day of treatment(about 21 days))