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NCT00016445 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Growth Hormone in Children With Cystic Fibrosis

A Phase 2 study of Cystic Fibrosis, sponsored by University of Utah.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
9
Study locations

NCT00016445 is a Phase 2 study of Cystic Fibrosis that has completed, run by University of Utah. The registered enrollment target is 40 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (78% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT00016445, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target
9
Study locations

Study Summary

OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis. II. Determine the effect of growth hormone on pulmonary function in these patients. III. Determine the impact of this drug on the quality of life in these patients. IV. Determine if the clinical response from this drug is sustained in these patients.

Conditions Studied

Cystic Fibrosis

Interventions

  • DRUG growth hormone

Study Locations (9)

Texas

  • Southwest Medical Center at Dallas - Dallas
  • Cook Children's Medical Center - Fort Worth - Fort Worth

Arizona

  • Phoenix Children's Hospital - Phoenix

California

  • Children's Hospital of Orange County - Orange

Indiana

  • James Whitcomb Riley Hospital for Children - Indianapolis

Missouri

  • Washington University - St Louis

Ohio

  • Children's Medical Center - Dayton - Dayton

Oklahoma

  • T.L. Carey, M.D. and Associates - Tulsa

Utah

  • Primary Children's Medical Center - Salt Lake City

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2001-02
Phase Phase 2

Sponsor

University of Utah

818 total trials

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What the Registry Record Tells You About NCT00016445

The ClinicalTrials.gov registry entry for NCT00016445 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (78% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which growth hormone is the first listed.

NCT00016445 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Texas, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT00016445 about?

NCT00016445 is a clinical study titled "Phase II Study of Growth Hormone in Children With Cystic Fibrosis". OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis. II. Determine the effect of growth hormone on pulmonary function in these patients. III. Determine the impact of this drug on the quality of life in t...

What is the current status of trial NCT00016445?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2001-02.

What conditions does trial NCT00016445 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT00016445?

The interventions under investigation include: growth hormone (DRUG).

Who is sponsoring clinical trial NCT00016445?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00016445 being conducted?

This trial has 9 study locations across Arizona, California, Indiana, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.