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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673062
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: SCH 900538 Drug: Pseudoephedrine Drug: Placebo Capsules Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: SCH 900538 Drug: SCH 900538
(4X50mg Capsules)

Active Comparator: Encapsulated pseudoephedrine
Encapsulated pseudoephedrine (2X30 mg immediate release tablets)
Drug: Pseudoephedrine
Encapsulated pseudoephedrine (2X30 mg immediate release tablets)
Other Name: Sudafed

Placebo Comparator: Placebo Capsules Drug: Placebo Capsules

Primary Outcome Measures :
  1. 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 Measures :
  1. Average change from baseline in nasal congestion at each evaluation time point. [ Time Frame: Over 12 hours. ]
  2. 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. ]
  3. 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. [ Time Frame: Over the first 4-hours and 12-hour study periods. ]
  4. 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. ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00673062     History of Changes
Other Study ID Numbers: P05031
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action