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NCT00434278 · ClinicalTrials.gov registry record · Phase 4

A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

A Phase 4 study, sponsored by Genentech.

Terminated
Registry status
Phase 4
Development phase
27
Enrollment target

NCT00434278 is a Phase 4 study that was terminated before completion, run by Genentech. The registered enrollment target is 27 participants.

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The verdict

NCT00434278, a Phase 4 study, was terminated before completion, sponsored by Genentech.

TERMINATED
Registry status
Phase 4
Development phase
27 participants
Enrollment target

Study Summary

This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

Interventions

  • DRUG placebo
  • DRUG Dornase alfa

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2007-03
Est. Completion 2008-11
Phase Phase 4

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT00434278

The ClinicalTrials.gov registry entry for NCT00434278 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00434278 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00434278 about?

NCT00434278 is a clinical study titled "A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)". This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients mu...

What is the current status of trial NCT00434278?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2007-03. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00434278?

The interventions under investigation include: placebo (DRUG), Dornase alfa (DRUG).

Who is sponsoring clinical trial NCT00434278?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

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

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.