Comparison of recovery of adrenal gland function following short and long term steroid treatment

Comparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapy

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005790-23-GB

Enrollment

Registered

2012-06-06

Start date

2012-07-17

Completion date

Unknown

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal recovery following long and short term steroid treatment. MedDRA version: 14.1 Level: LLT Classification code 10066550 Term: Chronic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10000842 Term: Acute lymphatic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10008953 Term: Chronic

Interventions

Product Name: Prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 53-03-2 Current Sponsor code: N/A Concentration unit: mg/m2 milligram(s)/square meter Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria for the two categories include. Short-term Glucocorticosteroid tratment group: Patients with newly diagnosed Acute Lymoblastic Leukemia (above 1 year of age) presenting to Birmingham Children’s Hospital, receiving high dose dexamethasone for 8 weeks) Glucocorticosteroid (GC) therapy Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Exclusion criteria for short and long term GC groups include, GC use for any other underlying conditions including use of topical or inhaled steroids. Unwilling, or unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoint is adrenal recovery, as defined by the time taken for the adrenals to recover (peak 30min cortisol >550nmol/L) following short or long term corticosteroid therapy, i.e from the last GC dose to the first normal ACTH test. For comparison of categorical data between the short- and long-term GC group, and between the two GC weaning groups, Chi-square and Fisher’s exact tests are used, giving binomial confidence intervals for % recovering at each time point. ;Timepoint(s) of evaluation of this end point: Time points after last GC dose: day 7±1, day 14±1, day 21±1 and day 35±1. First normal synacthen test ends the study participation, i.e. if synacthen test is normal already on day 7±1, no further testing at other time points. Adrenal recovery is defined as the time taken for the adrenals to recover (peak 30min cortisol >550nmol/L) following short or long term corticosteroid therapy, i.e from the last GC dose to the first normal ACTH test.;Main Objective: The primary research question is to compare how quickly the adrenal glands take to recover following short term (4 weeks) or long term (more than 2 months) steroid treatment.;Secondary Objective: The secondary research question in the long term steroid users is whether there is a difference in adrenal recovery time in children on two different types of steroid medications.	—

Measure

Time frame

Primary end point(s): The primary endpoint is adrenal recovery, as defined by the time taken for the adrenals to recover (peak 30min cortisol >550nmol/L) following short or long term corticosteroid therapy, i.e from the last GC dose to the first normal ACTH test. For comparison of categorical data between the short- and long-term GC group, and between the two GC weaning groups, Chi-square and Fisher’s exact tests are used, giving binomial confidence intervals for % recovering at each time point. ;Timepoint(s) of evaluation of this end point: Time points after last GC dose: day 7±1, day 14±1, day 21±1 and day 35±1. First normal synacthen test ends the study participation, i.e. if synacthen test is normal already on day 7±1, no further testing at other time points. Adrenal recovery is defined as the time taken for the adrenals to recover (peak 30min cortisol >550nmol/L) following short or long term corticosteroid therapy, i.e from the last GC dose to the first normal ACTH test.;Main Objective: The primary research question is to compare how quickly the adrenal glands take to recover following short term (4 weeks) or long term (more than 2 months) steroid treatment.;Secondary Objective: The secondary research question in the long term steroid users is whether there is a difference in adrenal recovery time in children on two different types of steroid medications.

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Secondary

Measure	Time frame
Secondary end point(s): A self-administered questionnaire to be completed by the patient or parent on each visit, evaluating the symptoms and signs of steroid withdrawal syndrome ;Timepoint(s) of evaluation of this end point: Frequency of signs/symptoms of the steroid withdrawal syndrome and the peak cortisol in nmol/l at which this occurs at day 7±1, day 14±1, day 21±1 and day 35±1 after last GC dose.	—

Measure

Time frame

Secondary end point(s): A self-administered questionnaire to be completed by the patient or parent on each visit, evaluating the symptoms and signs of steroid withdrawal syndrome ;Timepoint(s) of evaluation of this end point: Frequency of signs/symptoms of the steroid withdrawal syndrome and the peak cortisol in nmol/l at which this occurs at day 7±1, day 14±1, day 21±1 and day 35±1 after last GC dose.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026