MedDataX Logo

The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

NCT ID: NCT01739634

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea Medullary Thyroid Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diarrhea Medullary thyroid cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Drug

After a 1 week run-in period CASAD will be administered TID for 1 week. Each dose will be 2 500mg CASAD capsules. Patients will be followed for two weeks post active drug administration.

Group Type EXPERIMENTAL

CASAD

Intervention Type DRUG

CASAD is provided in 500mg capsules.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CASAD

CASAD is provided in 500mg capsules.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Calcium Aluminosilicate Anti-Diarrheal.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with medullary thyroid cancer
* Men and women from all ethnic and racial groups
* Diarrhea ( \>=3 loose bowel movements per day)
* Duration of diarrhea of at least 1 week

Exclusion Criteria

* Patients with MEN 2b (since these patients may have megacolon)
* Patients taking any clay products
* History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
* Patients who cannot comply with medications
* Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
* Pregnancy or lactation
* Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Salient Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maria E Cabanillas, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAL 2012-0584

Identifier Type: -

Identifier Source: org_study_id