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Biomarkers of Prednisolone Treatment (P05888)

NCT00971724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-05-22

No results posted yet for this study

Summary

Primary objective:

* To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.

Secondary objectives:

* To describe the PK of prednisolone and PD of a series of biomarkers.
* To identify biomarkers that reflect side effects of prednisolone.
* To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

Conditions

Interventions

DRUG

Placebo

Oral administration, once daily, for 15 days

DRUG

Prednisolone

Oral administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-10-31
Completion
2008-03-31

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Entities

Drugs
Diseases
Companies

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 NCT00971724 on ClinicalTrials.gov