|
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism Clinical research trials and Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism. Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism  Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism
For Condition: Hyperinsulinism
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Children's Hospital of Philadelphia
Synopsis: OBJECTIVES: Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study. Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 3 Months/18 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I
Total Enrollment: 16
Location and Contact Information:
Overall Study Official:
PinchasCohen, Study Chair, Children's Hospital of Philadelphia
Additional Information:
Study ID Numbers: 199/13382; CHP-FDR001181-DBPC
Study Start Date: May 1998
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004700
Other Hyperinsulinism Studies:
1. Genomewide Search for Loci Underlying Metabolic Syndrome
2. Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism
3. Lipoprotein Metabolism in Hypertensive African-Americans
4. Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
5. Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Related Studies:
Other Hyperinsulinism Clinical Trials
Other Clinical Trials
Other Clinical Trials
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism
|
|
|
|
|
|
|
|
