Clinical trials: HPA
Phenylketonuria
Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period
The primary objective of the study is to evaluate the proportion of responders (that is, greater than or equal to [>=] 30 percent reduction from Baseline in blood phenylalanine [Phe] level) to treatment with Kuvan® (sapropterin…
- Trial name
- ENDURE (NCT01082328)
- Testing
- Kuvan®
- Where
- Norway
- Volunteers
- 59 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Tetrahydrobiopterin Deficiencies, Hyperphenylalaninemia, Non-Phenylketonuric
Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency
The purpose of this study is to evaluate the ability of Phenoptin to control blood phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4 deficiency and to evaluate the safety of Phenoptin in this…
- Trial name
- NCT00355264
- Testing
- Phenoptin
- Where
- 10 sites in United States, Germany
- Volunteers
- 12 people
- Sponsor
- BioMarin Pharmaceutical
Atopic Dermatitis
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with…
- Trial name
- NCT03847389
- Testing
- Clobetasol propionate 0.05% Topical Oil
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Hill Dermaceuticals, Inc.
Psoriasis, Atopic Dermatitis
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic…
- Trial name
- NCT01137032
- Testing
- Pandel Cream 0.1%
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Atopic Dermatitis
Cutivate Lotion HPA Axis Pediatric Study
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
- Trial name
- NCT00546000
- Testing
- Fluticasone propionate 0.05% lotion
- Where
- 10 sites in United States
- Volunteers
- 56 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Scalp Psoriasis
Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
- Trial name
- NCT01083758
- Testing
- LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- LEO Pharma
Asthma
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
- Trial name
- NCT01086410
- Testing
- Fluticasone Furoate/GW642444 Inhalation Powder, Prednisolone Oral Capsule
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 185 people
- Sponsor
- GlaxoSmithKline
Asthma
Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma
Inhaled corticosteroids (ICS) have a number of known class effects including hypothalamic-pituitary-adrenocortical (HPA) axis suppression.
- Trial name
- NCT02483975
- Testing
- FF, Montelukast, Albuterol/Salbutamol
- Where
- 17 sites in United States, South Africa
- Volunteers
- 111 people
- Sponsor
- GlaxoSmithKline
BH4 Deficiency, Hyperphenylalaninemia
A Study of PTC923 (CNSA-001) in Primary Tetrahydrobiopterin (BH4) Deficient Participants With Hyperphenylalaninemia
This study has been designed to demonstrate the safety, pharmacokinetics (PK) and preliminary efficacy of PTC923 (CNSA-001) in reducing blood phenylalanine concentrations in participants with hyperphenylalaninemia due to primary…
- Trial name
- NCT03519711
- Testing
- PTC923
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- PTC Therapeutics
Rhinitis, Allergic, Perennial and/or Seasonal
Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol…
- Trial name
- NCT01154153
- Testing
- Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ), Claritin® Syrup
- Where
- 8 sites in United States
- Volunteers
- 140 people
- Sponsor
- Sanofi
Allergic Rhinitis
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to…
- Trial name
- NCT01697956
- Testing
- BDP
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Psoriasis
DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.
- Trial name
- HPA axis (NCT02131324)
- Testing
- DFD06 Cream, Clobetasol Propionate Cream 0.05%
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- Promius Pharma, LLC
Psoriasis Vulgaris
Effect of LEO 90100 on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis VulgarisExtensive Psoriasis Vulgaris
A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.
- Trial name
- NCT01600222
- Testing
- LEO 90100
- Where
- 10 sites in Canada
- Volunteers
- 37 people
- Sponsor
- LEO Pharma
Osteoarthritis of the Knee
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.
- Trial name
- NCT01487200
- Testing
- FX006 10 mg, FX006 40 mg, FX006 60 mg
- Where
- 2 sites in Australia
- Volunteers
- 24 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Plaque Psoriasis
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and…
- Trial name
- NCT01698333
- Testing
- 122-0551
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Therapeutics, Inc.
Psoriasis Vulgaris
An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
- Trial name
- NCT02038569
- Testing
- LEO 80185 gel
- Where
- 35 sites in United States, Canada and 5 more
- Volunteers
- 125 people
- Sponsor
- LEO Pharma
Plaque Psoriasis
DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
- Trial name
- NCT02527421
- Testing
- DFD01 Spray
- Where
- 8 sites in United States
- Volunteers
- 3 people
- Sponsor
- Primus Pharmaceuticals
Plaque Psoriasis
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
- Trial name
- BDS1307 (NCT02070965)
- Testing
- DFD01 Spray, Comp01 Lotion
- Where
- 12 sites in United States
- Volunteers
- 75 people
- Sponsor
- Primus Pharmaceuticals
Psoriasis Vulgaris
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
- Trial name
- NCT02387853
- Testing
- LEO 90100
- Where
- 9 sites in United States, Netherlands and 2 more
- Volunteers
- 117 people
- Sponsor
- LEO Pharma
Perennial Allergic Rhinitis
Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis
To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
- Trial name
- NCT01033825
- Testing
- Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg, Ciclesonide Aqueous Nasal Spray 200 mcg
- Where
- 6 sites in United States
- Volunteers
- 310 people
- Sponsor
- Sumitomo Pharma America, Inc.