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Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCH 900538

Pseudoephedrine

Placebo Capsules

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must be 18 to 65 years of age, of either sex, and of any race.
Subjects must have a history of SAR due to ragweed for the last two consecutive ragweed seasons.
Subjects must be skin-test positive for the ragweed pollen allergen used in the Environmental Exposure Unit (pollen chamber at the Screening Visit or within 12 months prior to the Screening Visit.
Subjects must develop a pre-defined severity of allergy symptoms within 90-minute after entering the pollen chamber during the pollen challenge at the Priming visit (Visit 2), and prior to dosing (Visit 3), in order to qualify for the study.
Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to randomization at the Treatment Visit. Female subjects and female partners of male subjects must be using an acceptable form of birth control during the study.
Blood pressure and pulse rate must be within normal ranges.

Exclusion Criteria:

Subjects who have had an upper or lower respiratory tract infection within approximately 28 days (4 weeks) before Priming (Visit 2) and thereafter.
Subjects who have a dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
Subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
Subjects who have used any investigational drugs, including placebo, within 30 days of Screening or for the duration of this stud, or who are participating in any other clinical study.
Subjects with a history of rhinitis medicamentosa.
Subjects with a history of anaphylaxis or severe or serious reaction to skin testing.
Subjects who are being medically treated for any of the following conditions: narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy; current treatment with monoamine oxidase (MAO) inhibitors.
Subjects with a history of a positive test, or are symptomatic, for HIV, TB (not due to vaccination), and hepatitis B (not due to vaccination) or hepatitis C.
Subjects with asthma that requires medication other than occasional (<=3 uses per week) use of an inhaled short-acting b-2 agonist.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SCH 900538

Encapsulated pseudoephedrine

Placebo Capsules

Arm Description

Encapsulated pseudoephedrine (2X30 mg immediate release tablets)

Outcomes

Primary Outcome Measures

Average change from baseline in nasal congestion scores over the first 4-hour observation period.

Secondary Outcome Measures

Average change from baseline in nasal congestion at each evaluation time point.

Average change from baseline in total symptoms, total symptoms minus congestion, total nasal symptoms, total nasal symptoms minus congestion, total non-nasal symptoms, and individual symptoms scores.

Onset of action: defined as the first time point at which a sustained, statistically significant (P<=0.05) reduction relative to placebo in an efficacy variable (eg, nasal congestion) up to a pre-specified time point.

Average change from baseline in PNIF over the first 4-hour and 12-hour study periods and at each time point.

Full Information

NCT ID

NCT00673062

First Posted

May 5, 2008

Last Updated

October 8, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00673062

Brief Title

Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)

Official Title

Study of the Decongestant Effect of SCH 900538 Compared With Placebo and Pseudoephedrine as Active Control in Subjects With Seasonal Allergic Rhinitis (SAR) Exposed to Pollen in an Environmental Exposure Unit

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant, pseudoephedrine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SCH 900538

Arm Type

Experimental

Arm Title

Encapsulated pseudoephedrine

Arm Type

Active Comparator

Arm Description

Encapsulated pseudoephedrine (2X30 mg immediate release tablets)

Arm Title

Placebo Capsules

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SCH 900538

Intervention Description

(4X50mg Capsules)

Intervention Type

Drug

Intervention Name(s)

Pseudoephedrine

Other Intervention Name(s)

Sudafed

Intervention Description

Encapsulated pseudoephedrine (2X30 mg immediate release tablets)

Intervention Type

Drug

Intervention Name(s)

Placebo Capsules

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Average change from baseline in nasal congestion scores over the first 4-hour observation period.

Time Frame

Over the first 4-hour observation period.

Secondary Outcome Measure Information:

Title

Average change from baseline in nasal congestion at each evaluation time point.

Time Frame

Over 12 hours.

Title

Average change from baseline in total symptoms, total symptoms minus congestion, total nasal symptoms, total nasal symptoms minus congestion, total non-nasal symptoms, and individual symptoms scores.

Time Frame

Over the first 4 hour and 12-hour study periods.

Title

Time Frame

Over the first 4-hours and 12-hour study periods.

Title

Average change from baseline in PNIF over the first 4-hour and 12-hour study periods and at each time point.

Time Frame

Over the first 4-hour and 12-hour study periods.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be 18 to 65 years of age, of either sex, and of any race. Subjects must have a history of SAR due to ragweed for the last two consecutive ragweed seasons. Subjects must be skin-test positive for the ragweed pollen allergen used in the Environmental Exposure Unit (pollen chamber at the Screening Visit or within 12 months prior to the Screening Visit. Subjects must develop a pre-defined severity of allergy symptoms within 90-minute after entering the pollen chamber during the pollen challenge at the Priming visit (Visit 2), and prior to dosing (Visit 3), in order to qualify for the study. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to randomization at the Treatment Visit. Female subjects and female partners of male subjects must be using an acceptable form of birth control during the study. Blood pressure and pulse rate must be within normal ranges. Exclusion Criteria: Subjects who have had an upper or lower respiratory tract infection within approximately 28 days (4 weeks) before Priming (Visit 2) and thereafter. Subjects who have a dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator. Subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Subjects who have used any investigational drugs, including placebo, within 30 days of Screening or for the duration of this stud, or who are participating in any other clinical study. Subjects with a history of rhinitis medicamentosa. Subjects with a history of anaphylaxis or severe or serious reaction to skin testing. Subjects who are being medically treated for any of the following conditions: narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy; current treatment with monoamine oxidase (MAO) inhibitors. Subjects with a history of a positive test, or are symptomatic, for HIV, TB (not due to vaccination), and hepatitis B (not due to vaccination) or hepatitis C. Subjects with asthma that requires medication other than occasional (<=3 uses per week) use of an inhaled short-acting b-2 agonist.

12. IPD Sharing Statement

Learn more about this trial

Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)

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