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Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis 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 I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis Clinical research trials and Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis 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 I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis. Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis 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 I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis 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.

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Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis



Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis

For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development , SciClone Pharmaceuticals
Synopsis: OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis. II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study. There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation. All patients return for a follow up evaluation 1 week after dosing.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: - Mild cystic fibrosis - Not pregnant or nursing Negative pregnancy test
Total Enrollment: 35

Location and Contact Information:

Overall Study Official:
EduardoMartins,  Study Chair,  SciClone Pharmaceuticals


Additional Information:
Study ID Numbers:  199/13364;  SCICLONE-FDA-OP-97-1
Study Start Date: September 1997
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004428

Other Cystic Fibrosis Studies:
1. Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol with Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

2. Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis

3. A Pilot Trial of Phenylbutyrate/Genistein Duotherapy (for Cystic Fibrosis)

4. Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)

5. Bone Health of People with Cystic Fibrosis

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