StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study
NCT ID: NCT02082054
Last Updated: 2014-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
125 participants
INTERVENTIONAL
2014-03-31
2014-05-31
Brief Summary
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Detailed Description
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Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.36 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.24 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.12 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg Atropine 0.24 mg
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PSE 120 mg, CM 8 mg, Atr 0.36 mg
Pseudoephedrine 120 mg,chlorpheniramine 8 mg, atropine 0.36 mg tablet dosed BID for 7.5 days
PSE 120 mg, CM 8 mg, Atr 0.36 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg, Atr 0.24 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg tablets dosed BID for 7.5 days
PSE 120 mg, CM 8 mg, Atr 0.24 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg, Atr 0.12 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 dosed BID for 7.5 days
PSE 120 mg, CM 8 mg, Atr 0.12 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
Atropine 0.24 mg
Atropine 0.24 mg tablets dosed BID for 7.5 days
Atropine 0.24 mg
Atropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
Interventions
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PSE 120 mg, CM 8 mg, Atr 0.36 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg, Atr 0.24 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg, Atr 0.12 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
Atropine 0.24 mg
Atropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of moderate to severe SAR for at least two years; defined as having a score of 2 or more on a 0-3 point scale
3. Documentation of sensitivity will be obtained from medical records or positive skin testing or in vitro specific IgE test.
4. Have a TNSS score of 6 with at least an average of 2.0 in the rhinorrhea sub-score during the placebo-run in phase.
5. Is a non-pregnant, non-lactating female who is postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study.
6. If female of childbearing potential, must agree to use listed acceptable birth control methods...
7. If female of childbearing potential, has a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening
8. Is able to swallow whole tablets of orally administered medication
9. Is able to understand and provide signed informed consent
Exclusion Criteria
2. Is currently undergoing chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super potent topical corticosteroids
3. Has taken any of the following medications in the indicated time period prior to study enrolment:
* Intranasal, opthalmic, or systemic corticosteroids (1 month)
* Intranasal cromolyn (2 weeks)
* Intranasal or systemic decongestants (3 days)
* Intranasal or systemic antihistamines (7 days) or leukotriene inhibitors (7 days)
4. Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
5. Has a history of allergic reaction to or known sensitivity to the active or inactive ingredients in the investigational products used in this study
6. Chronic use of concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication
7. Rhinitis medicamentosa
8. A history of glaucoma
9. Has known or suspected pregnancy, planned pregnancy, or lactation (for female patients)
10. Is currently receiving immunotherapy, unless at stable maintenance dose for at least 1 month.
11. Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy.
12. Plans to travel outside the study area for a substantial portion of the study period
13. Has a history in the last 2 years or current evidence of abuse of illicit drugs, prescription medications, or alcohol that, in the opinion of the Investigator, would interfere with adherence to study requirements.
14. Has exposure to any investigational agent within 30 days prior to study entry.
15. Has clinically significant mental illness (to be determined by the Investigator)
16. Has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk
12 Years
60 Years
ALL
No
Sponsors
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Magna Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen J Pollard, MD
Role: PRINCIPAL_INVESTIGATOR
Family Allergy and Asthma
Locations
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Clinical Research Atlanta
Stockbridge, Georgia, United States
Family Allergy and Asthma Institute
Louisville, Kentucky, United States
National Allergy, Asthma & Urticaria Centers of Charleston, PA
Charleston, South Carolina, United States
Central Texas Health Research
New Braunfels, Texas, United States
Countries
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Other Identifiers
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MAGNA2014-001
Identifier Type: -
Identifier Source: org_study_id