A Study in Adult and Pediatric Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00034515
First received: April 29, 2002
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Cystic Fibrosis
Drug: denufosol tetrasodium (INS37217) Inhalation Solution
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • assess safety and tolerability

Secondary Outcome Measures:
  • assess effects of INS37217 on sputum weight and symptoms

Enrollment: 63
Study Start Date: June 2001
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034515

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034515     History of Changes
Other Study ID Numbers: 08-102
Study First Received: April 29, 2002
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014