DiarrheaPhase 1/2NCT01739634
The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
A Phase 1/2 study testing CASAD in people with Diarrhea and Medullary Thyroid Cancer, run by Salient Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diarrhea, Medullary Thyroid Cancer
- What is being tested?
- CASAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Maria E Cabanillas, MD contact
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Maria E Cabanillas, MD
Ramona Dadu, MD
About this study
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.
- Conditions
- Diarrhea, Medullary Thyroid Cancer
- Being tested
- CASAD
- Keywords
- Diarrhea, Medullary thyroid cancer
- Medical subject headings
- Diarrhea, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASADDrug
Also called Calcium Aluminosilicate Anti-Diarrheal.
CASAD is provided in 500mg capsules.
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Experimental | 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. Receives: Drug: CASAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in treatment of diarrhea
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.
Measured: 1 week
Secondary outcomes (3)
Functional impact of CASAD
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)
Measured: 1 week
Effect on thyroid function tests
To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption
Measured: 1 week
Changes in MDASI-THY scores
To examine changes in MDASI-THY scores after treatment with CASAD
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salient Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739634
- Sponsor's protocol ID
- SAL 2012-0584
- Status last verified
- Nov 2012
- First submitted
- 29 Nov 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01739634
- Acronym / sponsor ID
- SAL 2012-0584
- Conditions
- Diarrhea, Medullary Thyroid Cancer
- Keywords
- Diarrhea, Medullary thyroid cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Salient Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Experimental | Drug: CASADAfter 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASADAlso: Calcium Aluminosilicate Anti-Diarrheal.CASAD is provided in 500mg capsules. | Drug | Active Drug |
Primary outcome
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.
3 secondary outcomes
Functional impact of CASAD
Time frame: 1 week
Effect on thyroid function tests
Time frame: 1 week
Changes in MDASI-THY scores
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria E Cabanillas, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CASAD in people with Diarrhea and Medullary Thyroid Cancer, run by Salient Pharmaceuticals Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria E Cabanillas, MD (mcabani@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in treatment of diarrhea (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.