COLOCORT SUMMARY
Colocort® (hydrocortisone) is anti-inflammatory corticosteroid. Hydrocortisone rectal suspension is a convenient disposable single-dose enema designed for ease of self-administration.
Colocort® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.
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NEWS HIGHLIGHTS
Clinical Trials Related to Colocort (Hydrocortisone Rectal)
The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism [Recruiting]
This study aims at assessing the effect of today's standard of hydrocortisone dosage versus
previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL
and IHCL) after a standardised fat load followed by a short-term aerobic exercise in
patients with corticotropic pituitary insufficiency.
Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia [Recruiting]
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia [Completed]
This study will test a new, extended release form of hydrocortisone called Chronocort in
patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of
the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the
sex hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and
prednisone) are currently used to treat CAH, but finding the best dose of these drugs that
effectively lowers androgens without causing undesirable side effects, such as weight gain
and slow growth rate in children, is often difficult to achieve.
Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this
study. Children 16 years of age and older are eligible with confirmation by bone age that
they are no longer growing.
Participants undergo the following tests and procedures during two inpatient visits one
month apart at the NIH Clinical Center:
- Medical history and physical examination.
- Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients
begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day
for 1 month.
- Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for
frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for
chemistries, blood count, pregnancy test in women, and for serial tests (up to 26
samples in a 24-hour period) to measure hormone levels.
- 24-hour urine test.
- Height and weight measurements.
Between the two hospitalizations, patients are contacted by NIH weekly to check for possible
side effects from Chronocort. Two weeks after the first visit, patients also will have blood
drawn by their regular doctor or a local clinic. A few days before the second
hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and
well being.
About 30 days after discharge from the second hospitalization, patients are followed up with
a telephone call to see how they are doing.
Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency [Completed]
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
Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration [Completed]
The current study will test the causal relationship between elevated levels of cortisol and
the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to
environmental threat. The investigators predict that carriers of the short allele of the
serotonin transporter gene who have elevated cortisol levels will be most sensitive to
threatening environments, whereas carriers of the long allele who do not have elevated
cortisol (placebo subjects) will be least sensitive.
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