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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00034515 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Eligibility| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| The Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Maryland | |
| The Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Minnesota | |
| University of Minnesota Medical School | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, North Carolina | |
| University of North Carolina Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center | |
| Seattle, Washington, United States, 98105 | |
| Study Director: | Amy Schaberg, BSN |
More Information
| ClinicalTrials.gov Identifier: | NCT00034515 History of Changes |
| Other Study ID Numbers: | 08-102 |
| Study First Received: | April 29, 2002 |
| Last Updated: | September 13, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |