NCT00034515

Brief Summary

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

April 29, 2002

Last Update Submit

February 13, 2015

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • assess safety and tolerability

Secondary Outcomes (1)

  • assess effects of INS37217 on sputum weight and symptoms

Interventions

denufosol tetrasodium (INS37217) Inhalation SolutionDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • FEV1 40-70% (adults)
  • FEV1 \>/=50% (pediatrics)
  • oxygen saturation \>90%
  • clinically stable
  • willing to stay overnight

You may not qualify if:

  • abnormal renal or liver function
  • receiving corticosteroids exceeding 10mg/day or 20 mg every other day
  • received intravenous or aerosolized antibiotics 1 week prior to dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Deterding R, Retsch-Bogart G, Milgram L, Gibson R, Daines C, Zeitlin PL, Milla C, Marshall B, Lavange L, Engels J, Mathews D, Gorden J, Schaberg A, Williams J, Ramsey B; Cystic Fibrosis Foundation Therapeutics Development Network. Safety and tolerability of denufosol tetrasodium inhalation solution, a novel P2Y2 receptor agonist: results of a phase 1/phase 2 multicenter study in mild to moderate cystic fibrosis. Pediatr Pulmonol. 2005 Apr;39(4):339-48. doi: 10.1002/ppul.20192.

    PMID: 15704203RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Amy Schaberg, BSN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2002

First Posted

April 30, 2002

Study Start

June 1, 2001

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

February 16, 2015

Record last verified: 2015-02