glycerol has been researched along with Cough in 10 studies
Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.
Cough: A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions, or to prevent aspiration of foreign materials into the lungs.
Excerpt | Relevance | Reference |
---|---|---|
"In a double-blind trial, 29 patients were treated for stable, chronic bronchitis with iodinated glycerol (Organidin, 60 mg four times daily; n = 16) or placebo (n = 13)." | 9.07 | Treatment of stable chronic bronchitis with iodinated glycerol: a double-blind, placebo-controlled trial. ( Repsher, LH, 1993) |
"In a double-blind trial, 29 patients were treated for stable, chronic bronchitis with iodinated glycerol (Organidin, 60 mg four times daily; n = 16) or placebo (n = 13)." | 5.07 | Treatment of stable chronic bronchitis with iodinated glycerol: a double-blind, placebo-controlled trial. ( Repsher, LH, 1993) |
"Prior influenza vaccination had no effect on study outcome." | 2.84 | Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections. ( Adkins, I; Arters, K; Buchheit, K; Esper, F; Ghannoum, MA; Mukherjee, PK; Salata, RA, 2017) |
"An acute cough is usually consequent to upper respiratory tract infections and is self-resolving within a few weeks." | 2.72 | Acute cough in children and adolescents: A systematic review and a practical algorithm by the Italian Society of Pediatric Allergy and Immunology. ( Brambilla, I; Caffarelli, C; Calvani, M; Cardinale, F; Chiappini, E; Ciprandi, G; Cravidi, C; Del Giudice, MM; Duse, M; Licari, A; Manti, S; Marseglia, GL; Martelli, A; Minasi, D; Pajno, G; Peroni, DG; Tosca, MA, 2021) |
"Many products for treating cough contain natural components." | 2.72 | Natural remedies for acute post-viral cough in children. ( Ciprandi, G; De Filippo, M; Marseglia, GL; Murgia, V; Tosca, MA; Votto, M, 2021) |
" Safety endpoints included adverse events, hyperammonemic crises (HACs), and growth and development." | 1.46 | Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years. ( Berry, SA; Diaz, GA; Ficicioglu, C; Harding, CO; Lichter-Konecki, U; Longo, N; McCandless, SE; Robinson, B; Smith, WE; Vockley, J; Zori, R, 2017) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (20.00) | 18.7374 |
1990's | 2 (20.00) | 18.2507 |
2000's | 1 (10.00) | 29.6817 |
2010's | 2 (20.00) | 24.3611 |
2020's | 3 (30.00) | 2.80 |
Authors | Studies |
---|---|
Eccles, R | 1 |
Marseglia, GL | 2 |
Manti, S | 1 |
Chiappini, E | 1 |
Brambilla, I | 1 |
Caffarelli, C | 1 |
Calvani, M | 1 |
Cardinale, F | 1 |
Cravidi, C | 1 |
Duse, M | 1 |
Martelli, A | 1 |
Minasi, D | 1 |
Del Giudice, MM | 1 |
Pajno, G | 1 |
Peroni, DG | 1 |
Tosca, MA | 2 |
Licari, A | 1 |
Ciprandi, G | 2 |
Murgia, V | 1 |
Votto, M | 1 |
De Filippo, M | 1 |
Berry, SA | 1 |
Longo, N | 1 |
Diaz, GA | 1 |
McCandless, SE | 1 |
Smith, WE | 1 |
Harding, CO | 1 |
Zori, R | 1 |
Ficicioglu, C | 1 |
Lichter-Konecki, U | 1 |
Robinson, B | 1 |
Vockley, J | 1 |
Mukherjee, PK | 1 |
Esper, F | 1 |
Buchheit, K | 1 |
Arters, K | 1 |
Adkins, I | 1 |
Ghannoum, MA | 1 |
Salata, RA | 1 |
Repsher, LH | 1 |
Morgan, EJ | 1 |
Petty, TL | 1 |
Block, SH | 1 |
Lewy, RB | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)[NCT02246218] | Phase 4 | 27 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo to Prevent Acute Upper Respiratory Disease and Respiratory Virus Infections[NCT02644135] | 100 participants (Actual) | Interventional | 2013-01-31 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants < 2 months of age, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment." (NCT02246218)
Timeframe: Up to Day 4
Intervention | percentage of participants (Number) |
---|---|
RAVICTI: Age 0 to < 2 Months | 100 |
"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants 2 months of age and older, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment." (NCT02246218)
Timeframe: Up to Day 4
Intervention | percentage of participants (Number) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 100 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 1321.18 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 246.126 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 115.3 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 98.98 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 4.197 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 9.85 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 7.422 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 1384.12 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 583.835 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 102.1 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 69.39 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 20.62 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 11.72 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 6.573 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 280.936 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 374.53 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 46.2 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 4.8 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 1.697 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 8.383 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 9.39 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 36.52 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 62.45 |
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 42.44 |
HAC is defined as having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension was calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group. (NCT02246218)
Timeframe: Day 8 through up to Month 6
Intervention | HACs per half-year of patient exposure (Number) |
---|---|
RAVICTI: Age 0 to < 2 Months | 0.003 |
HAC is defined having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension is calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group. (NCT02246218)
Timeframe: Day 8 through up to Month 6
Intervention | HACs per half-year of patient exposure (Number) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 0.005 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 84.97 | 26.81 | 25.16 | 50.05 | 18.77 | 57.43 | 43.65 | 33.41 | 8.75 | 25.75 | 2.50 | 16.10 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 122.43 | -54.50 | 7.80 | -16.33 | -13.00 | 0.25 | -2.20 | 30.80 | 22.20 | 39.00 | 48.00 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 508.83 | 21.04 | -27.62 | -15.09 | -113.98 | -99.82 | -138.16 | -56.08 | -181.50 | -103.75 | -184.00 | -219.93 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 750.43 | -184.33 | -174.60 | -374.00 | -252.75 | -370.25 | -113.20 | -446.53 | -450.50 | -149.00 | 195.00 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 142.68 | -49.09 | -1.62 | -20.46 | -67.32 | -75.45 | -35.94 | -73.09 | -178.50 | -139.50 | 1.00 | -55.31 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 54.86 | 2.67 | 4.20 | -25.67 | -20.25 | -20.00 | -16.40 | -6.73 | -13.33 | -18.00 | 1.50 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 133.67 | -81.91 | -60.80 | -51.66 | -82.82 | -118.55 | -11.85 | -115.09 | -249.50 | -195.75 | 6.00 | -82.54 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 90.86 | -0.83 | 9.80 | -33.00 | -31.25 | -39.50 | -25.40 | -19.13 | -34.37 | -40.00 | -1.50 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 593.80 | 47.85 | -2.46 | 34.96 | -95.21 | -42.39 | -94.51 | -22.66 | -172.75 | -78.00 | -181.50 | -203.83 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 872.86 | -238.83 | -166.80 | -390.33 | -265.75 | -370.00 | -115.40 | -415.73 | -428.30 | -110.00 | 243.00 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 181.49 | -63.96 | -39.04 | -23.86 | -74.41 | -98.67 | 2.64 | -90.40 | -238.25 | -137.00 | 38.00 | -72.78 |
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 171.43 | 4.00 | 40.60 | -27.33 | -31.50 | -56.00 | -21.60 | -11.90 | -48.87 | -46.00 | 5.00 |
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | -0.0544 | -0.2158 | -0.2598 | -0.1617 | -0.0264 | 0.0828 | 0.0136 | 0.4614 | 0.6646 | 0.6830 | 0.3308 | 0.7743 |
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 0.8107 | -0.2385 | -0.0249 | 0.1815 | 0.4434 | 0.1484 | 0.2497 | 0.6407 | 0.4164 | -0.2997 | -0.2038 | 0.5581 |
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 0.7143 | -0.2105 | -0.0704 | 0.1065 | 0.3365 | 0.1043 | 0.1842 | 0.4875 | 0.2944 | -0.3661 | -0.2214 | 0.4310 |
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | -0.1980 | 0.2336 | 0.2006 | 0.2684 | 0.2372 | 0.1810 | 0.2902 | 0.1679 | 0.1308 | 0.1595 | 0.1050 | 0.7341 |
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 0 to < 2 Months | 11.1 | 46.2 | 62.5 | 34.6 | 22.8 | 35.2 |
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 2 Months to < 2 Years | 18.78 | 6.50 | 7.29 | 2.60 | 4.48 | 4.31 |
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, End of Trial (up to Month 15)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | End of trial | |
RAVICTI: Age 0 to < 2 Months | 23.7 | 14.6 | 12.3 | 14.4 | 6.4 | 13.2 | 5.5 | 11.8 | 6.0 | 4.9 | 11.6 |
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, Month 18, End of Trial (up to Month 18)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 15 | Month 18 | End of trial | |
RAVICTI: Age 2 Months to < 2 Years | 5.82 | 4.44 | 3.69 | 4.65 | 7.14 | 3.27 | 1.59 | 4.10 | 2.04 | 1.64 | 7.0 |
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 0 to < 2 Months | 3530.43 | 1828 | 1746 | 2260 | 3530.43 | 4404 |
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 2 Months to < 2 Years | 3273 | 4140 | 3145 | 5202 | 3950 | 7561 |
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, End of Trial (up to Month 15)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | End of trial | |
RAVICTI: Age 0 to < 2 Months | 4643 | 4517 | 4116 | 7037 | 2826 | 6973 | 5883 | 7006 | 5847 | 3915 | 6939 |
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, End of Trial (up to Month 18)
Intervention | μg/mL (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | End of trial | |
RAVICTI: Age 2 Months to < 2 Years | 8859 | 6274 | 7386 | 11456 | 21416 | 6129 | 5347 | 9357 | 2580 | 6400 | 5250 | 25333 |
An AE is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related. (NCT02246218)
Timeframe: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 10.67 [6.142] months).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
≥ 1 TEAE | ≥ 1 Related TEAE | ≥ 1 Serious TEAE | ≥ 1 Serious Related TEAE | Fatal Outcome TEAE | ≥ 1 TEAE Leading to Study Discontinuation | |
RAVICTI: Age 0 to < 2 Months | 16 | 10 | 11 | 0 | 0 | 1 |
An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related. (NCT02246218)
Timeframe: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
≥ 1 TEAE | ≥ 1 Related TEAE | ≥ 1 Serious TEAE | ≥ 1 Serious Related TEAE | Fatal Outcome TEAE | ≥ 1 TEAE Leading to Study Discontinuation | |
RAVICTI: Age 2 Months to < 2 Years | 10 | 4 | 6 | 0 | 1 | 1 |
Measured by medical record review. (NCT02644135)
Timeframe: Through study duration, an average of 3 months
Intervention | Number of acute respiratory illnesses (Number) |
---|---|
Halo Oral Spray | 4 |
Halo Placebo | 2 |
(NCT02644135)
Timeframe: Through study duration, an average of 3 months
Intervention | participants (Number) |
---|---|
Halo Oral Spray | 2 |
Halo Placebo | 4 |
3 reviews available for glycerol and Cough
Article | Year |
---|---|
The Powerful Placebo Effect in Cough: Relevance to Treatment and Clinical Trials.
Topics: Antitussive Agents; Clinical Trials as Topic; Coloring Agents; Cough; Flavoring Agents; Glycerol; Ho | 2020 |
Acute cough in children and adolescents: A systematic review and a practical algorithm by the Italian Society of Pediatric Allergy and Immunology.
Topics: Acute Disease; Adolescent; Allergy and Immunology; Antitussive Agents; Apitherapy; Child; Child, Pre | 2021 |
Natural remedies for acute post-viral cough in children.
Topics: Acute Disease; Adolescent; Antitussive Agents; Apitherapy; Biological Products; Child; Cough; Glycer | 2021 |
3 trials available for glycerol and Cough
Article | Year |
---|---|
Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections.
Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Anti-Infective Agents, Local; Cety | 2017 |
Treatment of stable chronic bronchitis with iodinated glycerol: a double-blind, placebo-controlled trial.
Topics: Adult; Bronchitis; Chronic Disease; Cough; Double-Blind Method; Expectorants; Female; Glycerol; Huma | 1993 |
Summary of the National Mucolytic Study.
Topics: Aged; Bronchitis; Chest Pain; Consumer Behavior; Cough; Double-Blind Method; Expectorants; Female; G | 1990 |
4 other studies available for glycerol and Cough
Article | Year |
---|---|
Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years.
Topics: Ammonia; Child, Preschool; Cough; Disease Management; Drug-Related Side Effects and Adverse Reaction | 2017 |
Best drugs for what ails you: the brands to buy--and those to skip.
Topics: Acetaminophen; Anesthetics, Local; Cetirizine; Chlorpheniramine; Common Cold; Cough; Dextromethorpha | 2009 |
Goiter complicating therapy with iodinated glycerol (Organidin).
Topics: Adolescent; Cough; Expectorants; Female; Follow-Up Studies; Glycerol; Goiter; Humans; Iodine; Thyroi | 1973 |
Tracheotomy avoidance. Glycerine vocal cord injection.
Topics: Aged; Aorta; Cough; Female; Fluorocarbon Polymers; Glottis; Glycerol; Humans; Injections; Laryngosco | 1970 |