Crofelemer 125 MG [Mytesi] for Diarrhea

Phase-Based Progress Estimates
Taipei Veterans General Hospital, Taipei, TaiwanDiarrhea+5 MoreCrofelemer 125 MG [Mytesi] - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is a 24-week study of crofelemer to see if it is safe and effective in preventing diarrhea in adult patients with solid tumors being treated with targeted cancer therapy.

Eligible Conditions
  • Cancer Therapy-Related Diarrhea
  • Prevention of Diarrhea
  • Symptomatic Relief of Diarrhea
  • Chemotherapy-related Diarrhea
  • Targeted Therapy-related Diarrhea
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Initial 12-week (Stage 1) period of the study.

For the entire 12-week double-blind placebo-controlled treatment period (The Stage 1 Primary Treatment Phase).
Frequency of Number of Loose/watery Stools
Initial 12-week (Stage 1) period of the study.
Fecal Incontinence
Maximum Number of Weekly Loose/Watery Stools
Proportion of Durable, Clinical Responders

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

256 Total Participants · 2 Treatment Groups

Primary Treatment: Crofelemer 125 MG [Mytesi] · Has Placebo Group · Phase 3

Experimental Group · 1 Intervention: Crofelemer 125 MG [Mytesi] · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: initial 12-week (stage 1) period of the study.

Who is running the clinical trial?

Napo Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
170 Total Patients Enrolled
3 Trials studying Diarrhea
170 Patients Enrolled for Diarrhea
Pablo Okhuysen, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Pravin Chaturvedi, PhDStudy ChairNapo Pharmaceuticals

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can take standard chemotherapy drugs with your targeted cancer medication.

Frequently Asked Questions

Are people still able to join this study?

"The website says that this study is still looking for volunteers. The trial was first announced on October 7th, 2020 and the most recent update was May 2nd, 2022." - Anonymous Online Contributor

Unverified Answer

In how many distinct places is this trial being carried out?

"There are a total of 17 sites for this clinical trial, with the three primary locations being BRCR Global in Plantation, Florida; Inova Schar Cancer Institute in Fairfax, Virginia; and The West Clinic Research in Germantown, Tennessee." - Anonymous Online Contributor

Unverified Answer

How many test subjects are included in this experiment?

"The sponsor, Napo Pharmaceuticals, Inc., needs to recruit 256 eligible patients from multiple clinical trial sites including BRCR Global in Plantation, Florida and Inova Schar Cancer Institute in Fairfax, Virginia." - Anonymous Online Contributor

Unverified Answer

Does this research break new ground in the medical field?

"There are 2 ongoing trials for Crofelemer 125 MG [Mytesi], which began in 2019. Sponsored by Napo Pharmaceuticals, Inc., the first trial involved 100 patients and completed its Phase 4 drug approval stage. Since then, 18294 additional studies have been undertaken." - Anonymous Online Contributor

Unverified Answer

Has the FDA given their blessing to Crofelemer 125 MG [Mytesi]?

"Crofelemer 125 MG [Mytesi] is in Phase 3 of clinical trials, thus there is some data suggesting its efficacy and multiple rounds of safety testing have been completed. Our team rates it as a 3 on our safety scale." - Anonymous Online Contributor

Unverified Answer

What other scientific investigations have included Crofelemer 125 MG [Mytesi]?

"Crofelemer 125 MG [Mytesi] is being studied in 2 different clinical trials, 1 of which is currently in Phase 3. Although most of the research locations are situated in Lafayette, Colorado; there are a total of 15 medical centres running these trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.