Seasonal Allergic RhinitisPhase 2NCT00673062
Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)
A Phase 2 study testing SCH 900538 and Pseudoephedrine in people with Seasonal Allergic Rhinitis, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- SCH 900538 and Pseudoephedrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- SCH 900538, Pseudoephedrine, Placebo Capsules
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 900538Drug
(4X50mg Capsules)
PseudoephedrineDrug
Also called Sudafed
Encapsulated pseudoephedrine (2X30 mg immediate release tablets)
Placebo CapsulesDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SCH 900538 | Experimental | Not described Receives: Drug: SCH 900538 |
| Encapsulated pseudoephedrine | Active comparator | Encapsulated pseudoephedrine (2X30 mg immediate release tablets) Receives: Drug: Pseudoephedrine |
| Placebo Capsules | Placebo comparator | Not described Receives: Drug: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline in nasal congestion scores over the first 4-hour observation period.
Measured: Over the first 4-hour observation period.
Secondary outcomes (4)
Average change from baseline in nasal congestion at each evaluation time point.
Measured: Over 12 hours.
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.
Measured: Over the first 4 hour and 12-hour study periods.
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.
Measured: Over the first 4-hours and 12-hour study periods.
Average change from baseline in PNIF over the first 4-hour and 12-hour study periods and at each time point.
Measured: Over the first 4-hour and 12-hour study periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673062
- Sponsor's protocol ID
- P05031
- Status last verified
- Oct 2015
- First submitted
- 5 May 2008
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00673062
- Acronym / sponsor ID
- P05031
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCH 900538 | Experimental | Drug: SCH 900538 |
| Encapsulated pseudoephedrine | Active comparator | Drug: PseudoephedrineEncapsulated pseudoephedrine (2X30 mg immediate release tablets) |
| Placebo Capsules | Placebo comparator | Drug: Placebo Capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCH 900538(4X50mg Capsules) | Drug | SCH 900538 |
| PseudoephedrineAlso: SudafedEncapsulated pseudoephedrine (2X30 mg immediate release tablets) | Drug | Encapsulated pseudoephedrine |
| Placebo CapsulesPlacebo | Drug | Placebo Capsules |
Primary outcome
Average change from baseline in nasal congestion scores over the first 4-hour observation period.
Time frame: Over the first 4-hour observation period.
4 secondary outcomes
Average change from baseline in nasal congestion at each evaluation time point.
Time frame: Over 12 hours.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCH 900538 and Pseudoephedrine in people with Seasonal Allergic Rhinitis, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change from baseline in nasal congestion scores over the first 4-hour observation period. (time frame: Over the first 4-hour observation period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.