The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT01739634|
Recruitment Status : Unknown
Verified November 2012 by Salient Pharmaceuticals Incorporated.
Recruitment status was: Recruiting
First Posted : December 3, 2012
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Medullary Thyroid Cancer||Drug: CASAD||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: 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.
CASAD is provided in 500mg capsules.
Other Name: Calcium Aluminosilicate Anti-Diarrheal.
- Efficacy in treatment of diarrhea [ Time Frame: 1 week ]To evaluate the efficacy of CASAD 3 grams per day in reducing the severity of diarrhea after 1 week of treatment in patients with MTC.
- Functional impact of CASAD [ Time Frame: 1 week ]To explore the functional impact of CASAD and the relative impact of diarrhea in relation to other symptom issues using MDASI-THY (M.D. Anderson Symptom Inventory-Thyroid, appendix D)
- Effect on thyroid function tests [ Time Frame: 1 week ]To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption
- Changes in MDASI-THY scores [ Time Frame: 1 week ]To examine changes in MDASI-THY scores after treatment with CASAD
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739634
|Contact: Maria E Cabanillas, MDemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Maria E Cabanillas, MD|
|Sub-Investigator: Ramona Dadu, MD|