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A Study in Adult and Pediatric Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034515
Recruitment Status : Completed
First Posted : April 30, 2002
Last Update Posted : February 16, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2001
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Primary Outcome Measures :
  1. assess safety and tolerability

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034515

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Amy Schaberg, BSN
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00034515    
Other Study ID Numbers: 08-102
First Posted: April 30, 2002    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases