Trial · NCT00237380
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment in Total Chloride Transport | Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Primary | Number of Participants With a Chloride Transport Response | Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Primary | Number of Participants With a Chloride Transport Normalization Between Baseline and End of Treatment | Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Secondary | Change From Baseline in Nasal Chloride Secretion as Assessed by Transepithelial Potential Difference (TEPD) | Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Secondary | Change From Baseline in Sweat Chloride Concentration as Determined by Pilocarpine Iontophoresis | Baseline, Day 41 | |
| Secondary | Change From Baseline in CFTR Protein in Nasal Mucosa as Determined by Immunofluorescence | Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Secondary | Change From Baseline in Nonsense Mutation CFTR mRNA in Nasal Mucosa as Determined by Quantitative Polymerase Chain Reaction (PCR) Assay | Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Secondary | Change From Baseline in Number of Neutrophils in Blood | Baseline Up to Day 56 | |
| Secondary | Change From Baseline in Pulmonary Function as Measured by Spirometry | Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Secondary | Change From Baseline in Body Weight | Baseline of Cycle 1 and Cycle 2, Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days) | |
| Secondary | Compliance with Study Treatment | Baseline Up to Day 56 | |
| Secondary | Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Ataluren | 0 (predose), 1, 2, 3, and 4 hours (hrs) postdose of the midday dose; 0 (predose), 1, 2, 3, 4, and 12 hrs postdose of the evening dose on Day 1 and Day 27 | |
| Secondary | PK: Maximum Plasma Concentration (Cmax) of Ataluren | 0 (predose), 1, 2, 3, and 4 hrs postdose of the morning dose; 0 (predose), 1, 2, 3, and 4 hrs postdose of the midday dose; and 0 hrs (predose), 1, 2, 3, 4, and 12 hrs postdose of the evening dose on Days 1 and 13 of Cycles 1 and 2 (1 cycle=28 days) | |
| Secondary | PK: Area Under the Plasma Concentration Time Curve (AUC) of Ataluren | 0 (predose), 1, 2, 3, and 4 hrs postdose of the morning dose; 0 (predose), 1, 2, 3, and 4 hrs postdose of the midday dose; and 0 hrs (predose), 1, 2, 3, 4, and 12 hrs postdose of the evening dose on Days 1 and 13 of Cycles 1 and 2 (1 cycle=28 days) | |
| Secondary | PK: Terminal Elimination Half Life (T1/2) of Ataluren | 0 (predose), 1, 2, 3, and 4 hrs postdose of the morning dose; 0 (predose), 1, 2, 3, and 4 hrs postdose of the midday dose; and 0 hrs (predose), 1, 2, 3, 4, and 12 hrs postdose of the evening dose on Days 1 and 13 of Cycles 1 and 2 (1 cycle=28 days) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00237380/registered