Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004428 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: CPX

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 1999

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

Mild cystic fibrosis
Not pregnant or nursing Negative pregnancy test

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004428

Responsible Party

Study ID Numbers ^ICMJE

199/13364, SCICLONE-FDA-OP-97-1

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

SciClone Pharmaceuticals

Investigators ^ICMJE

Study Chair:

Eduardo Martins

SciClone Pharmaceuticals

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP