Back to results

A Study in Adult and Pediatric Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

denufosol tetrasodium (INS37217) Inhalation Solution

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: FEV1 40-70% (adults) FEV1 >/=50% (pediatrics) oxygen saturation >90% clinically stable willing to stay overnight Exclusion Criteria: 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

Sites / Locations

Outcomes

Primary Outcome Measures

assess safety and tolerability

Secondary Outcome Measures

assess effects of INS37217 on sputum weight and symptoms

Full Information

NCT ID

NCT00034515

First Posted

April 29, 2002

Last Updated

February 13, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00034515

Brief Title

A Study in Adult and Pediatric Patients With Cystic Fibrosis

Official Title

Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

June 2001 (undefined)

Primary Completion Date

August 2002 (Actual)

Study Completion Date

August 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

denufosol tetrasodium (INS37217) Inhalation Solution

Primary Outcome Measure Information:

Title

assess safety and tolerability

Secondary Outcome Measure Information:

Title

assess effects of INS37217 on sputum weight and symptoms

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Schaberg, BSN

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

15704203

Citation

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.

Results Reference

result

Learn more about this trial

A Study in Adult and Pediatric Patients With Cystic Fibrosis

We'll reach out to this number within 24 hrs