CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Lodotra +1 moredrug
Likely dose
Cortancyl 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00686335
NCT00686335Phase 2Completed
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A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

Amgen·interventional·Posted May 29, 2008·Updated Dec 17, 2024

In Brief

A Phase 2 clinical trial evaluating Lodotra and Cortancyl for Asthma. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2008
Enrollment StartJun 1, 2008
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.1 years ago

Interventions

Lodotradrug

Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period.

Cortancyldrug

Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl).