CASAD for Severe Diarrhea in the Emergency Department

NCT02018653 | Terminated Results

• 2 other identifiers: 2013-0452NCI-2014-01027
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can help to stop your diarrhea. Researchers also want to know if this drug can help decrease the duration of your diarrhea. In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study drug to learn if the study drug has any real effect.

Conditions

Cancer; Diarrhea

Keywords

Cancer; Diarrhea; Calcium Alumina-Silicate; CASAD; Calcium Aluminosilicate anti-diarrheal; Placebo; Sugar pill; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Time to Resolution of Diarrhea (TTRD)

  The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days.

  6 days

Study Arms (2)

Calcium Alumina-Silicate (CASAD)

EXPERIMENTAL

CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.

Drug: Calcium Alumina-Silicate (CASAD); Behavioral: Questionnaire

Placebo

PLACEBO COMPARATOR

Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.

Other: Placebo; Behavioral: Questionnaire

Interventions

Calcium Alumina-Silicate (CASAD) DRUG

1 gram by mouth every 6 hours for up to 6 days.

Also known as: CASAD, Calcium Aluminosilicate anti-diarrheal

Calcium Alumina-Silicate (CASAD)

Placebo OTHER

1 by mouth every 6 hours for up to 6 days.

Also known as: Sugar pill

Placebo

Questionnaire BEHAVIORAL

Questionnaire completion at baseline about diarrhea and other symptoms.

Also known as: Survey

Calcium Alumina-Silicate (CASAD); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients presenting to the EC or an acute care clinic for NCI grade \>/= 2 diarrhea
• Able to understand the description of the study and give informed consent
• Patients must be willing to and capable of providing frequent assessments for the duration of the study
• English-speaking

You may not qualify if:

• Patients will not be approached while they have : a) evidence of fever or severe abdominal pain, melena, overt blood in stool; b) any clinical suspicion or evidence of peritonitis or bowel perforation; c) s/p allogenic stem cell transplant
• Patients will not be approached if the EC physician thinks that the diarrhea is due to Crohn's disease, ulcerative colitis, Celiac disease, graft-versus-host disease, short-gut syndrome, neuroendocrine paraneoplastic syndromes (e.g., MEN, VIPomas, etc.), or malabsorption syndromes
• Patients who are status post stem cell transplantation (both autologous or allogenic)
• Patients who are status post immunotherapy (including those who are receiving or have received ipilimumab)
• Patients participating in other clinical trials for diarrhea
• Patients with a known allergy to any components of the CASAD formulation
• Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications
• Patients who cannot comply with medications
• Patients taking any clay products
• Patients with radiological evidence of megacolon, intraperitoneal free air, pneumatosis intestinalis, or fecal impaction
• History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up
• Patients who are pregnant
• Patients less than 18 years of age

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Salient Pharmaceuticals Incorporated: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Diarrhea

Interventions

Calcium Aluminosilicate; Sugars; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aluminum Silicates; Aluminum Oxide; Aluminum Compounds; Inorganic Chemicals; Silicates; Minerals; Oxides; Oxygen Compounds; Silicic Acid; Silicon Dioxide; Silicon Compounds; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Sai-Ching J. Yeung, MD
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Sai-Ching J. Yeung, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-07

Locations

US (1)