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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

August 21, 2007

Primary Completion Date

July 28, 2008

Study Completion Date

January 28, 2009

Conditions
Adrenal Insufficiency
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

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT00915343 - Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency | Biotech Hunter | Biotech Hunter