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Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency

NCT00915343 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-11-24

Study results available
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Summary

This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Conditions

Interventions

DRUG

hydrocortisone (modified release), oral tablet 20 and 5 mg

The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial

DRUG

Hydrocortisone, oral tablet, 10 mg

The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Maria Forss, MSc BA · DuoCort AB

  • Anna G Nilsson, MD, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-21
Primary Completion
2008-07-28
Completion
2009-01-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915343 on ClinicalTrials.gov