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NCT00775138 · ClinicalTrials.gov registry record · Phase 2

Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

A Phase 2 study of Bronchiectasis, sponsored by Insmed Incorporated.

Completed
Registry status
Phase 2
Development phase
64
Enrollment target
18
Study locations

NCT00775138 is a Phase 2 study of Bronchiectasis that has completed, run by Insmed Incorporated. The registered enrollment target is 64 participants, below the 383-participant average among 13 other Bronchiectasis trials with a reported enrollment target (83% lower). The trial reports 18 study locations across 3 states.

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The verdict

NCT00775138, a Phase 2 study of Bronchiectasis, has completed, sponsored by Insmed Incorporated.

COMPLETED
Registry status
Phase 2
Development phase
64 participants
Enrollment target
18
Study locations

Study Summary

This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

Conditions Studied

Bronchiectasis

Interventions

  • DRUG 280 mg Arikayce™
  • DRUG Matching Placebo for Cohort 1
  • DRUG 560 mg Arikayce™
  • DRUG Matching Placebo for Cohort 2

Study Locations (18)

Other

  • - Sofia
  • - Athens
  • - Mosdós
  • - Bangalore
  • - Hyderabad
  • - Manipal
  • - Mumbai
  • - Nagpur
  • - New Delhi
  • - Rabka-Zdrój
  • - Belgrade
  • - Kragujevac
  • - Niš
  • - Kiev
  • - Cambridge
  • - London

District of Columbia

  • - Washington D.C.

Pennsylvania

  • - Philadelphia

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2008-06-24
Est. Completion 2009-05-11
Phase Phase 2

Sponsor

Insmed Incorporated

31 total trials

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What the Registry Record Tells You About NCT00775138

The ClinicalTrials.gov registry entry for NCT00775138 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 383-participant average among 13 other Bronchiectasis trials with a reported enrollment target (83% lower). The listed sponsor is Insmed Incorporated, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bronchiectasis appearing as the primary indexed condition, and to 4 interventions - of which 280 mg Arikayce™ is the first listed.

NCT00775138 reports 18 study locations spanning 3 distinct geographic areas - top geographies include Other, District of Columbia, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00775138 about?

NCT00775138 is a clinical study titled "Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.". This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

What is the current status of trial NCT00775138?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2008-06-24. Estimated completion is 2009-05-11.

What conditions does trial NCT00775138 study?

This clinical trial studies the following conditions: Bronchiectasis.

What interventions are being tested in trial NCT00775138?

The interventions under investigation include: 280 mg Arikayce™ (DRUG), Matching Placebo for Cohort 1 (DRUG), 560 mg Arikayce™ (DRUG), Matching Placebo for Cohort 2 (DRUG).

Who is sponsoring clinical trial NCT00775138?

This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00775138 being conducted?

This trial has 18 study locations across District of Columbia, Pennsylvania. 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 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.