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StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study

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ClinicalTrials.gov Identifier: NCT02082054
Recruitment Status : Unknown
Verified February 2014 by Magna Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2014
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
Magna Pharmaceuticals, Inc.

Brief Summary:
This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p < 0.05.

Condition or disease Intervention/treatment Phase
Rhinitis, Seasonal, Allergic Drug: PSE 120 mg, CM 8 mg, Atr 0.36 mg Drug: PSE 120 mg, CM 8 mg, Atr 0.24 mg Drug: PSE 120 mg, CM 8 mg, Atr 0.12 mg Drug: PSE 120 mg, CM 8 mg Drug: Atropine 0.24 mg Phase 2

Detailed Description:

Actives in each of the five study arms:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older
Study Start Date : March 2014
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: 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
Other Name: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropine

Experimental: 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
Drug: 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
Other Name: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropine

Experimental: 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
Drug: 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
Other Name: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropine

Active Comparator: 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
Drug: PSE 120 mg, CM 8 mg
Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
Other Name: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton)

Experimental: Atropine 0.24 mg
Atropine 0.24 mg tablets dosed BID for 7.5 days
Drug: Atropine 0.24 mg
Atropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
Other Name: atropine sulfate




Primary Outcome Measures :
  1. Dose-ranging data for atropin [ Time Frame: 7.5 days ]
    To provide dose-ranging data for atropine and select a dose of Atropine for Phase 3 clinical development using Total Nasal Symptom Score (TNSS) as the primary endpoint plus recording of adverse events


Secondary Outcome Measures :
  1. Establish effect size for determining power and TNSS efficacy endpoint [ Time Frame: 7.5 days ]
    To establish an effect size of a Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine combination versus Pseudoephedrine 120 mg/Chlorpheniramine 8 mg to statistically power the pivotal phase of the study using TNSS as the primary endpoint


Other Outcome Measures:
  1. Establish safety/efficacy and appropriate dosage interval of investigational formulas [ Time Frame: 7.5 days ]
    1. Assess the instantaneous and reflective TNSS scores.
    2. To assess the effect of various doses of Atropine in combination with Pseudoephedrine 120 mg/Chlorpheniramine 8 mg on each of the four (4) individual components of the TNSS compared to Pseudoephedrine 120 mg/Chlorpheniramine 8 mg alone
    3. To assess if BID dosing is an appropriate dosing interval for the Pseudoephedrine/Chlorpheniramine/Atropine formulation
    4. To assess the effect of Atropine 0.24 mg alone on the change from baseline of each of the four (4) individual components of the TNSS
    5. To assess the safety and tolerability of Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine combination products compared to Pseudoephedrine 120 mg/Chlorpheniramine 8 mg product as well as the safety and tolerability of atropine 0.24 mg administered twice/day.
    6. To assess the incidence and severity of drowsiness



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and females of any ethnic group between 12 and 60 years of age.
  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:

  1. Has asthma requiring corticosteroid treatment
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082054


Locations
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United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Kentucky
Family Allergy and Asthma Institute
Louisville, Kentucky, United States, 40215
United States, South Carolina
National Allergy, Asthma & Urticaria Centers of Charleston, PA
Charleston, South Carolina, United States, 29406
United States, Texas
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Sponsors and Collaborators
Magna Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Stephen J Pollard, MD Family Allergy and Asthma
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Responsible Party: Magna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02082054    
Other Study ID Numbers: MAGNA2014-001
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: February 2014
Keywords provided by Magna Pharmaceuticals, Inc.:
rhinitis
seasonal
allergic
Additional relevant MeSH terms:
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Rhinitis
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Chlorpheniramine
Atropine
Pseudoephedrine
Ephedrine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents