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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2004-001883-39-AT |
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Date of registration:
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29/12/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Evaluate the Effect of the Coadministration of SCH 497079 (a Histamine 3 [H3] Receptor Antagonist) Plus Desloratadine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis Who Have Been Exposed to Pollen in the Vienna Challenge Chamber (VCC) - H3 POC
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Scientific title:
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Study to Evaluate the Effect of the Coadministration of SCH 497079 (a Histamine 3 [H3] Receptor Antagonist) Plus Desloratadine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis Who Have Been Exposed to Pollen in the Vienna Challenge Chamber (VCC) - H3 POC |
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Date of first enrolment:
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21/09/2004 |
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Target sample size:
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80 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001883-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Subjects must be willing to give written informed consent and adhere to dose and visit schedules.
2. Subjects must have the appropriate washout times from the prohibited medications (see Section 7.4.2.1.1).
3. Clinical laboratory tests (CBC, blood chemistries, urinalysis) at screening must be within normal limits or clinically acceptable to the investigator.
4. Subjects must skin test positive confirming hypersensitivity to Dactylis glomerata grass allergen extract which is cross reactive with pollen mixture used in the chamber, unless a positive test was obtained within the previous 12 months. IgE-mediated hypersensitivity must be documented by a positive response to the skin prick test with wheal diameter ?3 mm larger than diluent control.
5. Female subjects of childbearing potential must have a negative serum pregnancy test prior to treatment with study medication; a negative urine pregnancy test must be obtained at least every 28 days during study participation. Female subjects of childbearing potential must be using a medically accepted method of birth control (eg, double barrier method, oral contraceptive, Depo-Provera, or Norplant) prior to Screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the medically accepted methods of birth control if they become sexually active while participating in the study.
6. Subjects must have the following minimum symptom scores using a 0-3 scale at some point during each of the 120-minute screening period challenge sessions:
a. Nasal Congestion Score of at least 2;
b. Total Nasal Symptoms Score of at least 6 (symptoms are nasal congestion, nasal itching, sneezing, and rhinorrhea);
c. Total Non-nasal Symptoms Score of at least 2 (symptoms are itching/burning eyes, tearing/watering eyes, and itching of ears/palate.
7. Subjects must be in good health and free of any clinically significant disease (other than SAR) that would interfere with the study schedule or procedures, or compromise the subject’s safety.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Female subjects who are pregnant, intend to become pregnant during the study, or are nursing.
2. Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
3. Subjects who have used any investigational drugs, including placebo, within 30 days of study entry.
4. Subjects who are participating in any other clinical study.
5. Subjects who are part of the staff personnel directly involved with this study.
6. Subjects who are family members of the investigational study staff directly involved with this study.
7. Subjects who had an upper or lower respiratory tract infection within 4 weeks before screening, or who have a respiratory infection any time during the treatment phase of the study.
8. Subjects who have nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal airflow.
9. Subjects who have been previously enrolled (ie, signed informed consent) into this study.
10. Subjects with rhinitis medicamentosa.
11. Subjects with a history of anaphylaxis or severe or serious reaction to skin testing.
12. Subjects who have a known potential for hypersensitivity, allergy, or idiosyncratic reaction to any of the study drugs or excipients.
13. Subjects who, in the opinion of the investigator, are dependent upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Seasonal Allergic Rhinitis
MedDRA version: 7.0
Level: LLT
Classification code 10039776
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Intervention(s)
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Product Name: SCH 497079 100 mg capsule
Pharmaceutical Form: Capsule*
Current Sponsor code: SCH 497079
Other descriptive name: H3 Antagonist
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 mg-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Aerius 5 mg
Product Name: desloratadine
Product Code: SCH 34117
Pharmaceutical Form: Tablet
Current Sponsor code: desloratadine
Other descriptive name: SCH 34117
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5 mg-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: pseudoephedrine 240 mg
Product Code: SCH 4855
Pharmaceutical Form: Tablet
Current Sponsor code: Pseudoephedrin
Other descriptive name: SCH 4855
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240 mg-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: SCH 497079 10 mg capsule
Pharmaceutical Form: Capsule*
Current Sponsor code: SCH 497079
Other descriptive name: H3 Antagonist
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10 mg-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to evaluate the effect on nasal congestion of a maximally tolerated dose of SCH 497079, when taken in combination with DL 5 mg (identified in Phase 1 studies), in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen in the VCC. This objective will be accomplished by comparison of the effect on nasal congestion, over the 7.5 hour observation period, of the coadministration of DL 5 mg and SCH 497079 100 mg with that of DL 5 mg taken alone.
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Primary end point(s): The primary efficacy variable is the subjectively evaluated symptom of nasal congestion. The nasal decongestant effect is expressed as an average change from Baseline over the 7.5-hour evaluation period. The primary comparison for this variable is SCH 497079 100 mg plus DL 5 mg taken in combination vs DL 5 mg taken alone.
Pairwise comparisons will be made using linear contrasts of the treatment means obtained from an analysis of variance model that extracts sources of variation due to treatment, subject, and phase.
Summary statistics for the primary variable will be provided for the subject subgroups of sex and race (Caucasian and non-Caucasian).
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Secondary Objective: Key secondary objectives include calculation of the estimates of the following treatment differences over the 7.5-hour observation period and at each time point:
The comparison of the effect on nasal congestion of the coadministration of DL 5 mg and SCH 497079, at a 20 mg dose, with that of DL 5 mg taken alone.The comparison of the effect on nasal congestion of DL 5 mg, taken in combination with each of two dose levels of SCH 497079, 100 mg and 20 mg, versus concurrent administration of DL plus PSE 240 mg. Evaluation of the safety profiles among the five treatments of postdose vital signs and adverse events compared with predose evaluations. Single dose plasma SCH 497079, DL 3-OH DL, and pseudoephedrine concentrations and pharmacokinetic parameters will be listed and summarized using means, and percent coefficients of variation. In addition, an association between plasma concentrations and observed decongestant activity will be explored if the data allow.
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Secondary ID(s)
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N/A
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P02561
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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