CASAD for Severe Diarrhea in the Emergency Department

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Salient Pharmaceuticals Incorporated
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02018653
First received: December 17, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cancer
Diarrhea
Drug: Calcium Alumina-Silicate (CASAD)
Other: Placebo
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blinded Placebo-Controlled Pilot Trial of Calcium Alumina-Silicate (CASAD) in the Treatment of Severe Diarrhea (Grade 3 or 4) in Cancer Patients Presenting for Emergency Care

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Resolution of Diarrhea (TTRD) [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    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. Patients will be evaluated for the primary endpoint for up to 6 days.


Enrollment: 2
Study Start Date: December 2013
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium Alumina-Silicate (CASAD)
CASAD 1 gram by mouth every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
Drug: Calcium Alumina-Silicate (CASAD)
1 gram by mouth every 6 hours for up to 6 days.
Other Names:
  • CASAD
  • Calcium Aluminosilicate anti-diarrheal
Behavioral: Questionnaire
Questionnaire completion at baseline about diarrhea and other symptoms.
Other Name: Survey
Placebo Comparator: Placebo
1 by mouth every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
Other: Placebo
1 by mouth every 6 hours for up to 6 days.
Other Name: Sugar pill
Behavioral: Questionnaire
Questionnaire completion at baseline about diarrhea and other symptoms.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. 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
  3. Patients who are status post stem cell transplantation (both autologous or allogenic)
  4. Patients who are status post immunotherapy (including those who are receiving or have received ipilimumab)
  5. Patients participating in other clinical trials for diarrhea
  6. Patients with a known allergy to any components of the CASAD formulation
  7. Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications
  8. Patients who cannot comply with medications
  9. Patients taking any clay products
  10. Patients with radiological evidence of megacolon, intraperitoneal free air, pneumatosis intestinalis, or fecal impaction
  11. History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up
  12. Patients who are pregnant
  13. Patients less than 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018653

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Salient Pharmaceuticals Incorporated
Investigators
Principal Investigator: Sai-Ching J. Yeung, MD,PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02018653     History of Changes
Other Study ID Numbers: 2013-0452, NCI-2014-01027
Study First Received: December 17, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Diarrhea
Calcium Alumina-Silicate
CASAD
Calcium Aluminosilicate anti-diarrheal
Placebo
Sugar pill
Questionnaire
Survey

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium, Dietary
Antidiarrheals
Loperamide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014