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Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. 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 committed 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 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts 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 permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase I Randomized Study of CPX for the Treatment of Adult Patients with Mild Cystic Fibrosis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous 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. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis

2. Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients with Cystic Fibrosis

3. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis

4. A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis

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

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