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Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia Clinical research trials and Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia. Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia clinical trial. Human subjects often get the best healthcare available for their Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia  Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
For Condition: Hereditary Hemorrhagic Telangiectasia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Yale University
Synopsis: OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia. II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.
Details: PROTOCOL OUTLINE: This is a randomized study. One group of patients is treated with soy protein isolate for 12 weeks. The control group receives a placebo for 12 weeks. Patients cross to the alternate group following a 4-week washout.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Crossover Assignment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: - Hereditary hemorrhagic telangiectasia (HHT) with 2 of the following: - First-degree relative with HHT - History of recurrent epistaxis or gastrointestinal bleeding - Three or more skin telangiectasia - Migraine headache meeting International Headache Society criteria 3 or more times a month for more than 1 year - No pattern of daily headaches - No severe head trauma - No onset of headaches after 50 years of age - At least 1 month since migraine prophylaxis - At least 1 month since any of the following medications: Beta blockers; Calcium channel blockers; Divalproex sodium; Tricyclic antidepressants; Selective serotonin re-uptake inhibitors - Concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed - Creatinine no greater than 2.5 g/dL - No allergy to soy - No pregnant women - No women with intent to become pregnant
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
JoshuaKorzenik, Study Chair, Yale University
Additional Information:
Study ID Numbers: 199/11799; YALESM-8191
Study Start Date: January 1996
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004654
Other Hereditary Hemorrhagic Telangiectasia Studies:
1. Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
2. Study of the Natural History and Genotype-Phenotype Correlations of Hereditary Hemorrhagic Telangiectasia Patients
3. Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia
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Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
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