The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739634
|Contact: Maria E Cabanillas, MDfirstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Maria E Cabanillas, MD|
|Sub-Investigator: Ramona Dadu, MD|