Clinical trials: Histamine
Allergy Pollen, Allergic Reaction
Phleum Pratense and Dactylis Glomerata Allergen Extracts Standardization
The primary objective is to assess the concentration of each allergen extract (Phleum pratense and Dactylis glomerata) that induces a wheal size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution.
- Conditions
- Allergy Pollen, Allergic Reaction, Allergic Skin Reaction
- Trial name
- NCT06957496
- Testing
- Allergenic extracts
- Where
- Spain
- Volunteers
- 31 people
- Sponsor
- Inmunotek S.L.
Allergic Rhinitis
Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis
Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance
- Trial name
- NCT00533637
- Testing
- Cetirizine dihydrochloride (10 mg/ml) liposomal formulation, Cetirizine dihydrochloride (10 mg/ml) buffer solution
- Where
- Sweden
- Volunteers
- 28 people
- Sponsor
- Biolipox AB
Allergic Reaction, Allergic Skin Reaction
Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
- Conditions
- Allergic Reaction, Allergic Skin Reaction, Allergy Pollen
- Trial name
- NCT05532566
- Testing
- Allergenic extract
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Inmunotek S.L.
Allergic Rhinitis
Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.
- Trial name
- NCT00637585
- Testing
- Fexofenadine
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sanofi
Idiopathic Hypersomnia, Excessive Daytime Sleepiness
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
- Trial name
- NCT05458128
- Testing
- Pitolisant
- Where
- 32 sites in United States
- Volunteers
- 119 people
- Sponsor
- Harmony Biosciences Management, Inc.
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Perennial Allergic Rhinitis
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
- Trial name
- NCT01900054
- Testing
- Bepotastine besilate
- Where
- Japan
- Volunteers
- 58 people
- Sponsor
- Tanabe Pharma Corporation
Allergy to Grass Pollen (Secale Cereale)
Biological Standardization of Secale Cereale Allergen Extract
The objective of this study is to determine the biologic activity of a Secale cereale allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
- Trial name
- NCT01408238
- Testing
- Four different concentrations of Secale cereale allergen extract, positive control and negative control
- Where
- 2 sites in Spain
- Volunteers
- 35 people
- Sponsor
- Laboratorios Leti, S.L.
Histamine Intolerance
A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.
- Trial name
- NCT02418221
- Testing
- Drawing blood, measuring BP & pulse
- Where
- Austria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- IPSC AG
Allergy to Mites
Biological Standardization of Blomia Tropicalis Allergen Extract
The objective of this study is to determine the biologic activity of a Blomia tropicalis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
- Trial name
- NCT01597752
- Testing
- Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Laboratorios Leti, S.L.
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended
- Trial name
- NCT00917488
- Testing
- Standardization of allergenic extract (Gly. domesticus)
- Where
- Spain
- Volunteers
- 27 people
- Sponsor
- Laboratorios Leti, S.L.
Allergy to Alternaria Fungus
To Determine the Minimum Amount of Alternaria Alternata Allergen Extract Producing a Positive Skin Reaction.
The objetive of this study is to determine the minimum amount of Alternaria alternata allergen extract producing in a positive skin reaction.
- Trial name
- NCT01984528
- Testing
- four differente concentrations of Alternaria alternata allergen extract, positive control and negative control
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Laboratorios Leti, S.L.
Allergy to Tree Pollen
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Biological Standardization of Cupressus arizonica Allergen Extract.
- Trial name
- NCT02512653
- Testing
- Cupressus arizonica
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Laboratorios Leti, S.L.
Multiple Sclerosis, Relapsing-Remitting
Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis
This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).
- Trial name
- NCT01772199
- Testing
- GSK239512
- Where
- 43 sites in Bulgaria, Canada and 6 more
- Volunteers
- 131 people
- Sponsor
- GlaxoSmithKline
Brain Distribution of [11C]AZ12807110 and AZD5213
Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration
The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.
- Trial name
- NCT01194986
- Testing
- [11C]AZ12807110, AZD5213
- Where
- Sweden
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
GI Health
Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms
Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.
- Trial name
- NCT07835776
- Testing
- Active GI Health Product 1
- Where
- United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Radicle Science
Food Intolerance, Histamine Intolerance
Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of an oral diamine oxidase substitution…
- Trial name
- NCT03298568
- Testing
- DAOsin
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Sciotec Diagnostic Technologies GmbH
Immune System Diseases
Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts
Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol…
- Trial name
- MM09 (NCT02527122)
- Testing
- Allergen extracts
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Inmunotek S.L.
Healthy Subjects
Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner. 1.
- Trial name
- NCT04631276
- Testing
- TS-091
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Allergy to Grass Pollen
Biological Standardization of Poa Pratensis Allergen Extract
The objective of this study is to determine the biologic activity of a Poa pratensis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
- Trial name
- NCT01430117
- Testing
- Four different concentrations of Poa pratensis allergen extract, positive control and negative control
- Where
- 2 sites in Spain
- Volunteers
- 31 people
- Sponsor
- Laboratorios Leti, S.L.