glycerol has been researched along with Hypopituitarism in 11 studies
Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.
Hypopituitarism: Diminution or cessation of secretion of one or more hormones from the anterior pituitary gland (including LH; FOLLICLE STIMULATING HORMONE; SOMATOTROPIN; and CORTICOTROPIN). This may result from surgical or radiation ablation, non-secretory PITUITARY NEOPLASMS, metastatic tumors, infarction, PITUITARY APOPLEXY, infiltrative or granulomatous processes, and other conditions.
Excerpt | Relevance | Reference |
---|---|---|
"Abdominal obesity is associated with reduced 24-h plasma GH concentrations." | 2.70 | Hyposomatotropism blunts lipolysis in abdominally obese women. ( Ackermans, MT; Arndt, JW; Buijs, MM; Burggraaf, J; Cohen, AF; Frölich, M; Langendonk, JG; Meinders, AE; Pijl, H; Romijn, JA; Sauerwein, HP; Schoemaker, RC, 2002) |
"Abdominal obesity is associated with a blunted lipolytic response to fasting that may contribute to the preservation of adipose tissue mass." | 1.32 | Blunted lipolytic response to fasting in abdominally obese women: evidence for involvement of hyposomatotropism. ( Buijs, MM; Burggraaf, J; Cohen, AF; de Kam, ML; Frölich, M; Meinders, AE; Pijl, H; Romijn, JA; Sauerwein, HP; Wijbrandts, C, 2003) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 3 (27.27) | 18.7374 |
1990's | 2 (18.18) | 18.2507 |
2000's | 6 (54.55) | 29.6817 |
2010's | 0 (0.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Buijs, MM | 2 |
Burggraaf, J | 2 |
Langendonk, JG | 1 |
Schoemaker, RC | 1 |
Frölich, M | 2 |
Arndt, JW | 1 |
Cohen, AF | 2 |
Romijn, JA | 2 |
Ackermans, MT | 1 |
Sauerwein, HP | 2 |
Meinders, AE | 2 |
Pijl, H | 2 |
Wijbrandts, C | 1 |
de Kam, ML | 1 |
al-Shoumer, KA | 3 |
Beshyah, SA | 1 |
Niththyananthan, R | 2 |
Johnston, DG | 3 |
Ali, K | 1 |
Anyaoku, V | 2 |
Kousta, E | 1 |
Chrisoulidou, A | 1 |
Lawrence, NJ | 1 |
Lucidi, P | 1 |
Laureti, S | 1 |
Santoni, S | 1 |
Lauteri, M | 1 |
Busciantella-Ricci, N | 1 |
Angeletti, G | 1 |
Santeusanio, F | 1 |
De Feo, P | 1 |
Nørrelund, H | 1 |
Møller, N | 1 |
Nair, KS | 1 |
Christiansen, JS | 1 |
Jørgensen, JO | 1 |
McConnell, EM | 1 |
Atkinson, AB | 1 |
Ennis, C | 1 |
Hadden, DR | 1 |
McCance, DR | 1 |
Sheridan, B | 1 |
Bell, PM | 1 |
Johnson, RH | 2 |
Rennie, MJ | 2 |
Duguid, WP | 1 |
Walton, JL | 1 |
Webster, MH | 1 |
GEDDA, L | 1 |
DIRAIMONDO, F | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A, Randomised, Controlled, Two-armed, Two-period Cross-over, Multi-centre Phase II/III Study to Assess the Safety and Pharmacokinetics of Once-daily Oral Modified-release Hydrocortisone in Patients With Adrenal Insufficiency[NCT00915343] | Phase 2/Phase 3 | 64 participants (Actual) | Interventional | 2007-08-21 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The Rac was calculated as area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) on Day 28 divided by AUC0-24h on Day 1. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | ratio (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 1.11 |
Hydrocortisone Tablet TID - Part A | 1.03 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUCtau is defined as AUC during a dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour*nanomole per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 3962.0 |
Hydrocortisone Tablet TID - Part A | 4879.6 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 14 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.048 |
Hydrocortisone Tablet TID - Part A | 0.061 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.041 |
Hydrocortisone Tablet TID - Part A | 0.046 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour*nanomole per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 3962.0 |
Hydrocortisone Tablet TID - Part A | 4879.6 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.047 |
Hydrocortisone Tablet TID - Part A | 0.060 |
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.025 |
Hydrocortisone Tablet TID - Part A | 0.024 |
Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | nanomoles per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 165.1 |
Hydrocortisone Tablet TID - Part A | 203.3 |
Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.002 |
Hydrocortisone Tablet TID - Part A | 0.003 |
Diurnal fatigue was assessed at 8 ante meridian (AM), at 12 AM and at 4 post meridian (PM) by a visual analogue scale (VAS) based on 8 domains (energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity). Mean values were calculated for the morning (8 AM), the day (12 AM), the evening (4 PM) and mean per day (mean of 8 AM, 12 AM and 4 PM) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), Week 12
Intervention | scores on a scale (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | -3.1 |
Diurnal fatigue scores (Visual Analog Scale [VAS] scores of energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
Intervention | scores on a scale (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part B (All 6 Months) | -0.180 |
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
Intervention | scores on a scale (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part B (All 6 Months) | -1.09 |
The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
Intervention | scores on a scale (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part B (All 6 Months) | -0.739 |
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: 12 weeks
Intervention | scores on a scale (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 22.6 |
Hydrocortisone Tablet TID - Part A | 26.4 |
The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being. (NCT00915343)
Timeframe: 12 weeks
Intervention | scores on a scale (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 110.5 |
Hydrocortisone Tablet TID - Part A | 107.7 |
(NCT00915343)
Timeframe: 12 weeks
Intervention | nanomoles per 24 hours (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 385.7 |
Hydrocortisone Tablet TID - Part A | 425.9 |
Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets - Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose). (NCT00915343)
Timeframe: Weeks 4 up to 28
Intervention | percentage use (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 104.8 |
Hydrocortisone Tablet TID - Part A | 103.1 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | nanomoles per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 278.5 |
Hydrocortisone Tablet TID - Part A | 426.7 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | nanomoles per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 214.1 |
Hydrocortisone Tablet TID - Part A | 322.4 |
t1/2[5-14h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 14 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hours (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 4.60 |
Hydrocortisone Tablet TID - Part A | 18.4 |
t1/2[5-24h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 24 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hours (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 7.32 |
Hydrocortisone Tablet TID - Part A | 1.84 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | nanomoles per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 229.0 |
Hydrocortisone Tablet TID - Part A | 295.1 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.003 |
Hydrocortisone Tablet TID - Part A | 0.004 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | nanomoles per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 690.7 |
Hydrocortisone Tablet TID - Part A | 802.8 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | nanomoles per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 553.8 |
Hydrocortisone Tablet TID - Part A | 446.9 |
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | per liter (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.008 |
Hydrocortisone Tablet TID - Part A | 0.010 |
Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets - Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose). (NCT00915343)
Timeframe: Up to Month 6 follow-up
Intervention | percentage use (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 102.3 |
The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) was calculated by using the formula AUC%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter was to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t). Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | percentage of AUC (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 10.1 |
Hydrocortisone Tablet TID - Part A | 9.26 |
Percentage of fluctuation was calculated by using formula 100*(Cmax-minimum plasma concentration [Cmin])/Cavg,ss. It was peak trough fluctuation within one dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | percentage of fluctuation (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 429.7 |
Hydrocortisone Tablet TID - Part A | 396.2 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hours (Median) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.229 |
Hydrocortisone Tablet TID - Part A | 0.208 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | (hour per nanomole)*10^6 (Mean) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 2.26 |
Hydrocortisone Tablet TID - Part A | 2.32 |
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hours (Median) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 1.00 |
Hydrocortisone Tablet TID - Part A | 0.750 |
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hours (Median) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 5.00 |
Hydrocortisone Tablet TID - Part A | 6.00 |
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hours (Median) |
---|---|
Hydrocortisone MR Tablet OD - Part A | 0.250 |
Hydrocortisone Tablet TID - Part A | 0.167 |
"AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUC between specified timepoints included AUC0-4h, AUC4-12h, AUC6-12h, AUC12-24h, AUC0-10h, AUC4-10h, AUC6-10h, AUC10-24h, AUC(0-inf), AUC(24h-inf). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. Here, Nsignifies the number of participants evaluable for this outcome." (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Intervention | hour*nanomole per liter (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
AUC0-4h (N=61, 61) | AUC4-12h (N=61, 61) | AUC6-12h (N=61, 61) | AUC12-24h (N=61, 61) | AUC0-10h (N=61, 61) | AUC4-10h (N=61, 61) | AUC6-10h (N=61, 61) | AUC10-24h (N=61, 61) | AUC(0-inf) (N=52, 52) | AUC(24h-inf) (N=52, 52) | |
Hydrocortisone MR Tablet OD - Part A | 2053.7 | 1491.8 | 808.2 | 306.2 | 3388.4 | 1334.7 | 651.1 | 465.0 | 3972.6 | 195.3 |
Hydrocortisone Tablet TID - Part A | 1929.7 | 2302.5 | 1607.6 | 576.6 | 3768.7 | 1839.0 | 1144.1 | 1058.0 | 5162.8 | 410.4 |
The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value in the SF-36 questionnaire corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
Intervention | scores on a scale (Mean) | |
---|---|---|
Physical component | Mental component | |
Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 0.390 | -0.896 |
"Overall patient tolerability score assessed by patient and investigator, ranged from 1 (feeling poor on treatment) to 5 (feeling very well on treatment). The average total score ranges from 1 to 5 with a higher score representing better tolerability of the treatment. Questionnaire assessed by patient were I have been very poorly on the treatment, I haven't been very well (or less well) on the treatment, I have been acceptably well on the treatment, I have been well on the treatment and I have been very well on the treatment. Questionnaire assessed by investigator were The patient has been feeling very poorly on the treatment, The patient has not tolerated the treatment well, The patient has tolerated the treatment less well, The patient has tolerated the treatment well and The patient has tolerated the treatment very well." (NCT00915343)
Timeframe: 12 weeks
Intervention | scores on a scale (Mean) | |
---|---|---|
Patient | Investigator | |
Hydrocortisone MR Tablet OD - Part A | 4.28 | 4.26 |
Hydrocortisone Tablet TID - Part A | 4.36 | 4.33 |
The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value corresponds to better well-being. (NCT00915343)
Timeframe: 12 weeks
Intervention | scores on a scale (Mean) | |
---|---|---|
Physical component | Mental component | |
Hydrocortisone MR Tablet OD - Part A | 49.3 | 51.1 |
Hydrocortisone Tablet TID - Part A | 50.0 | 49.8 |
Participant Preference Questionnaire consisted of the following set of questions: 1. How large was the benefit with OD compared to TID and the responses were recorded as considerably poorer, somewhat poorer, comparable, large, very large; 2. How strongly concur with the following statement: I prefer novel OD to conventional TID and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly; 3. How strongly concur with the following statement: I prefer conventional TID to novel OD and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly. (NCT00915343)
Timeframe: Weeks 16 up to 28
Intervention | percentage of preference (Number) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Benefit compared OD to TID: Considerably poorer | Benefit compared OD to TID: Somewhat poorer | Benefit compared OD to TID: Comparable | Benefit compared OD to TID: Large | Benefit compared OD to TID: Very large | Prefer OD to TID: Strongly disagree | Prefer OD to TID: Disagree | Prefer OD to TID: Neutral | Prefer OD to TID: Strongly | Prefer OD to TID: Very strongly | Prefer TID to OD: Strongly disagree | Prefer TID to OD: Disagree | Prefer TID to OD: Neutral | Prefer TID to OD: Strongly | Prefer TID to OD: Very strongly | |
Hydrocortisone OD Versus TID | 3.8 | 5.7 | 5.7 | 20.8 | 64.2 | 3.7 | 3.7 | 5.6 | 25.9 | 61.1 | 39.6 | 35.4 | 12.5 | 4.2 | 8.3 |
Patient tolerability questionnaire was assessed by both patient and investigator, the responses were as follows: improvement, no change, worsening and were reported. (NCT00915343)
Timeframe: Baseline (week 0), month 6
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Improvement (Patient) | Improvement (Investigator) | No change (Patient) | No change (Investigator) | Worsening (Patient) | Worsening (Investigator) | |
Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 10.7 | 14.0 | 73.2 | 70.0 | 16.1 | 16.0 |
3 trials available for glycerol and Hypopituitarism
Article | Year |
---|---|
Hyposomatotropism blunts lipolysis in abdominally obese women.
Topics: Abdomen; Adipose Tissue; Body Mass Index; Female; Glycerol; Human Growth Hormone; Humans; Hypopituit | 2002 |
The effects of growth hormone replacement therapy on overnight metabolic fuels in hypopituitary patients.
Topics: 3-Hydroxybutyric Acid; Adult; Aged; Area Under Curve; Blood Glucose; Double-Blind Method; Fatty Acid | 2000 |
The effects on insulin action in adult hypopituitarism of recombinant human GH therapy individually titrated for six months.
Topics: 3-Hydroxybutyric Acid; Adult; Blood Glucose; Fatty Acids, Nonesterified; Female; Glycerol; Growth Ho | 2001 |
8 other studies available for glycerol and Hypopituitarism
Article | Year |
---|---|
Blunted lipolytic response to fasting in abdominally obese women: evidence for involvement of hyposomatotropism.
Topics: Abdomen; Adipose Tissue; Body Constitution; Body Mass Index; Case-Control Studies; Catecholamines; F | 2003 |
Effect of glucocorticoid replacement therapy on glucose tolerance and intermediary metabolites in hypopituitary adults.
Topics: Aged; Blood Glucose; Fatty Acids, Nonesterified; Female; Glucose Tolerance Test; Glycerol; Humans; H | 1995 |
Overnight metabolic fuel deficiency in patients treated conventionally for hypopituitarism.
Topics: 3-Hydroxybutyric Acid; Adult; Blood Glucose; Circadian Rhythm; Fatty Acids, Nonesterified; Female; G | 1996 |
Administration of recombinant human growth hormone on alternate days is sufficient to increase whole body protein synthesis and lipolysis in growth hormone deficient adults.
Topics: Adult; Analysis of Variance; Blood Glucose; C-Peptide; Drug Administration Schedule; Glycerol; Growt | 2000 |
Continuation of growth hormone (GH) substitution during fasting in GH-deficient patients decreases urea excretion and conserves protein synthesis.
Topics: Adult; Amino Acids; Blood Glucose; Calorimetry, Indirect; Fasting; Fatty Acids, Nonesterified; Femal | 2001 |
Metabolic changes with exercise in patients with hypopituitarism.
Topics: Fatty Acids, Nonesterified; Glycerol; Growth Hormone; Humans; Hypopituitarism; Lactates; Physical Ex | 1970 |
The effect of moderate exercise on blood metabolites in patients with hypopituitarism.
Topics: Adolescent; Adult; Blood Glucose; Carcinoma; Fatty Acids, Nonesterified; Female; Glycerol; Growth Ho | 1971 |
[CONTRIBUTION OF THE CLINICO-TWIN METHOD IN STUDY OF SEX ANOMALIES IN CHILDHOOD. (CASES OF TWINS WITH PHIMOSIS, HYPOSPADIAS, CRYPTORCHISM, HYPOPITUITARISM, ADIPOSO-GENITAL SYNDROME AND THE LAURENCE-MOON-BIEDL TYPE SYNDROME)].
Topics: Adolescent; Child; Cryptorchidism; Diseases in Twins; Humans; Hypopituitarism; Hypospadias; Infant; | 1965 |