Clinical trials: HPA
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
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)
The primary objective of this study is to demonstrate that there are no clinically relevant additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly administered with orally inhaled HFA-BDP.
- Trial name
- NCT00659048
- Testing
- Ciclesonide
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- AstraZeneca
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
Asthma
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal…
- Trial name
- NCT00163371
- Testing
- Ciclesonide
- Where
- Denmark
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
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
Perennial Allergic Rhinitis, Allergic Rhinitis
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.
- Conditions
- Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
- Trial name
- NCT00163488
- Testing
- Ciclesonide
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- AstraZeneca
Phenylketonurias, PAH Deficiency
Gene Therapy Clinical Study in Adult PKU
This is a Phase 1/2, open-label, randomized, concurrently-controlled, dose escalation study to evaluate the safety and efficacy of HMI-102 in adult PKU subjects with PAH deficiency.
- Trial name
- pheNIX (NCT03952156)
- Testing
- HMI-102
- Where
- 13 sites in United States
- Volunteers
- 10 people
- Sponsor
- Homology Medicines, Inc
Stress, Attention Disturbances
Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
The primary objective of the current study is to investigate the effect of two probiotic formulations on task-switching following acute stress in healthy, adult action video gamers.
- Trial name
- NCT05545813
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Lallemand Health Solutions
Phenylketonuria, Hyperphenylalaninaemia
PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
The objective of this study is to evaluate the safety of long-term treatment with Kuvan.
- Trial name
- PKUDOS (NCT00778206)
- Testing
- Kuvan
- Where
- 45 sites in United States
- Volunteers
- 1,887 people
- Sponsor
- BioMarin Pharmaceutical
Psoriasis
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
- Trial name
- NCT03058744
- Testing
- IDP-118 Lotion, HP Monad Lotion, Ultravate Cream
- Where
- 12 sites in United States
- Volunteers
- 94 people
- Sponsor
- Bausch Health Americas, Inc.
Atopic Dermatitis, Eczema
HPA Axis Study in Adults
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
- Trial name
- NCT01408511
- Testing
- Mapracorat
- Where
- 3 sites in South Africa
- Volunteers
- 23 people
- Sponsor
- Bayer
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
Rhinitis, Allergic, Perennial
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age…
- Trial name
- NCT00116883
- Testing
- GW685698X aqueous nasal spray
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- GlaxoSmithKline
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
Tetrahydrobiopterin Deficiency
Retrospective Observational Safety Effectiveness With Kuvan in hpA
A retrospective study to collect the effectiveness and safety data of the past treatment with KUVAN in Chinese patients with HPA caused by BH4 deficiency.
- Trial name
- ROSEKA (NCT03864029)
- Testing
- KUVAN
- Where
- China
- Volunteers
- 26 people
- Sponsor
- BioMarin Pharmaceutical