FREE TREATMENT REPORT

See ratings and reviews when you sign up for an account.

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, With a History of Grass Pollen-Induced Rhinoconjunctivitis, With or Without Asthma (Phase 3; Protocol No. P08067)

This study is currently Recruiting

October 2011 By Schering-Plough

First Recieved on April 6, 2011

Last Updated on October 31, 2011

Sponsor: Schering-Plough
Collaborators:
Information provided by: Schering-Plough
Identifier: NCT01385371

Purpose

This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Subjects will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those subjects receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:5 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma) - Must have a positive skin prick test response to Phleum pratense (Timothy grass) - Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass) - Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at Screening - Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor Exclusion Criteria: - Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS - Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed - Has received an immunosuppressive treatment within 3 months prior to the Screening Visit - Has a clinical history of severe asthma - Has a history of anaphylaxis with cardiorespiratory symptoms - Has a history of self-injectable epinephrine use - Has a history of chronic urticaria and angioedema - Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit - Has current severe atopic dermatitis - Is breast-feeding, pregnant, or intending to become pregnant - Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within the 5 years prior to the Screening Visit - Ongoing treatment with any specific immunotherapy at the time of the Screening Visit - Has a known history of allergy, hypersensitivity or intolerance to the ingredients of the study drug (except for Phleum pratense), rescue medications, or self-injectable epinephrine - Has 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. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers - Has used any investigational drugs within 30 days of the Screening Visit - Is participating in any other clinical study - Is a family member of the investigational study staff conducting this study - Is unable to meet medication washout requirements - Is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data - Has a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study

Investigators

Locations

  • Investigational Site 81

    Fresno, California 93720 United States

  • Investigational Site 176

    Redwood City, California 94003 United States

  • Investigational Site 154

    Roseville, California 95078 United States

  • Investigational Site 159

    Sacramento, California 95815 United States

  • Investigational Site 140

    Sacramento, California 95819 United States

  • Investigational Site 155

    San Francisco, California 94102 United States

  • Investigational Site 95

    San Jose, California 95117 United States

  • Investigational Site 188

    Stockton, California 95207 United States

  • Investigational Site 152

    Walnut Creek, California 94598 United States

  • Investigational Site 76

    Centennial, Colorado 80112 United States

  • Investigational Site 59

    Colorado Springs, Colorado 80907 United States

  • Investigational Site 92

    Denver, Colorado 80230 United States

  • Investigational Site 36

    Wheat Ridge, Colorado 80033 United States

  • Investigational Site 74

    Bridgeport, Connecticut 06606 United States

  • Investigational Site 35

    Waterbury, Connecticut 06708 United States

  • Investigational Site 75

    Boise, Idaho 83704 United States

  • Investigational Site 125

    Coeur d' Alene, Idaho 83814 United States

  • Investigational Site 17

    Eagle, Idaho 83616 United States

  • Investigational Site 122

    Meridian, Idaho 83642 United States

  • Investigational Site 131

    Meridian, Idaho 83642 United States

  • Investigational Site 72

    Twin Falls, Idaho 83301 United States

  • Investigational Site 163

    Dekalb, Illinois 60115 United States

  • Investigational Site 78

    Moline, Illinois 61265 United States

  • Investigational Site 28

    Normal, Illinois 61761 United States

  • Investigational Site 136

    Evansville, Indiana 47713-1227 United States

  • Investigational Site 107

    Fort Wayne, Indiana 46804 United States

  • Investigational Site 21

    Indianapolis, Indiana 46208 United States

  • Investigational Site 79

    Des Moines, Iowa 50312 United States

  • Investigational Site 157

    Dubuque, Iowa 52002 United States

  • Investigational Site 7

    Iowa City, Iowa 52240 United States

  • Investigational Site 19

    Lenexa, Kansas 66215 United States

  • Investigational Site 102

    Overland Park, Kansas 66210 United States

  • Investigational Site 98

    Overland Park, Kansas 66202 United States

  • Investigational Site 130

    Topeka, Kansas 66606 United States

  • Investigational Site 99

    Bangor, Maine 04401 United States

  • Investigational Site 56

    Baltimore, Maryland 21236 United States

  • Investigational Site 103

    Wheaton, Maryland 20902 United States

  • Investigational Site 97

    Brockton, Massachusetts 02301 United States

  • Investigational Site 121

    Gardner, Massachusetts 01440 United States

  • Investigational Site 153

    North Dartmouth, Massachusetts 02747 United States

  • Investigational Site 104

    Ann Arbor, Michigan 48106 United States

  • Investigational Site 41

    Novi, Michigan 48375 United States

  • Investigational Site 33

    Southfield, Michigan 48075 United States

  • Investigational Site 156

    Stevensville, Michigan 49127 United States

  • Investigational Site 55

    Ypsilanti, Michigan 48197 United States

  • Investigational Site 49

    Minneapolis, Minnesota 55402 United States

  • Investigational Site 46

    Plymouth, Minnesota 55441 United States

  • Investigational Site 118

    Columbia, Missouri 65203 United States

  • Investigational Site 14

    Kansas City, Missouri 64114 United States

  • Investigational Site 73

    Rolla, Missouri 65401 United States

  • Investigational Site 132

    Saint Louis, Missouri 63110 United States

  • Investigational Site 126

    St. Louis, Missouri 63141 United States

  • Investigational Site 31

    St. Louis, Missouri 63141 United States

  • Investigational Site 50

    Warrensburg, Missouri 64093 United States

  • Investigational Site 174

    Billings, Montana 59101 United States

  • Investigational Site 40

    Bozeman, Montana 59718 United States

  • Investigational Site 90

    Bellevue, Nebraska 68123 United States

  • Investigational Site 58

    Boys Town, Nebraska 68010 United States

  • Investigational Site 29

    Omaha, Nebraska 68130 United States

  • Investigational Site 53

    Omaha, Nebraska 68131 United States

  • Investigational Site 87

    Berkeley Heights, New Jersey 07922 United States

  • Investigational Site 12

    Brick, New Jersey 08724 United States

  • Investigational Site 181

    Little Silver, New Jersey 07739 United States

  • Investigational Site 38

    Ocean, New Jersey 07712 United States

  • Investigational Site 63

    Skillman, New Jersey 08858 United States

  • Investigational Site 64

    Teaneck, New Jersey 07666 United States

  • Investigational Site 91

    Verona, New Jersey 07044 United States

  • Investigational Site 143

    Brooklyn, New York 11229 United States

  • Investigational Site 123

    Cortland, New York 13045 United States

  • Investigational Site 32

    Newburgh, New York 12550 United States

  • Investigational Site 42

    North Syracuse, New York 13212 United States

  • Investigational Site 11

    Rochester, New York 14618 United States

  • Investigational Site 52

    Rochester, New York 14618 United States

  • Investigational Site 77

    Rockville Centre, New York 11570 United States

  • Investigational Site 127

    High Point, North Carolina 27262-4320 United States

  • Investigational Site 84

    Raleigh, North Carolina 27612 United States

  • Investigational Site 161

    Akron, Ohio 44308 United States

  • Investigational Site 20

    Canton, Ohio 44718 United States

  • Investigational Site 43

    Carlisle, Ohio 45005 United States

  • Investigational Site 6

    Cincinnati, Ohio 45231 United States

  • Investigational Site 189

    Cincinnati, Ohio 45246 United States

  • Investigational Site 134

    Cincinnati, Ohio 45249 United States

  • Investigational Site 5

    Cleveland, Ohio 44122 United States

  • Investigational Site 15

    Columbus, Ohio 43207 United States

  • Investigational Site 108

    Columbus, Ohio 43235 United States

  • Investigational Site 106

    Mogadore, Ohio 44260 United States

  • Investigational Site 39

    Sylvania, Ohio 43560 United States

  • Investigational Site 150

    Toledo, Ohio 43617 United States

  • Investigational Site 13

    Aschland, Oregon 97520 United States

  • Investigational Site 171

    Bend, Oregon 97701 United States

  • Investigational Site 82

    Corvallis, Oregon 97330 United States

  • Investigational Site 23

    Eugene, Oregon 97401 United States

  • Investigational Site 45

    Eugene, Oregon 97401 United States

  • Investigational Site 113

    Lake Oswego, Oregon 97035 United States

  • Investigational Site 116

    Medford, Oregon 97504 United States

  • Investigational Site 30

    Portland, Oregon 97202 United States

  • Investigational Site 165

    Altoona, Pennsylvania 16601 United States

  • Investigational Site 37

    Bethlehem, Pennsylvania 18020 United States

  • Investigational Site 114

    Collegeville, Pennsylvania 19426 United States

  • Investigational Site 26

    Harleysville, Pennsylvania 19438 United States

  • Investigational Site 88

    Hershey, Pennsylvania 17033 United States

  • Investigational Site 16

    Levittown, Pennsylvania 19056 United States

  • Investigational Site 160

    Phoenixville, Pennsylvania 19460 United States

  • Investigational Site 57

    Pittsburgh, Pennsylvania 15241 United States

  • Investigational Site 124

    Pittsburgh, Pennsylvania 15212 United States

  • Investigational Site 18

    Upland, Pennsylvania 19013 United States

  • Investigational Site 34

    East Providence, Rhode Island 02914 United States

  • Investigational Site 101

    Lincoln, Rhode Island 02865 United States

  • Investigational Site 67

    Providence, Rhode Island 02906 United States

  • Investigational Site 100

    Knoxville, Tennessee 37909 United States

  • Investigational Site 94

    Waco, Texas 76712 United States

  • Investigational Site 138

    Bountiful, Utah 84010 United States

  • Investigational Site 22

    Draper, Utah 84020 United States

  • Investigational Site 182

    Layton, Utah 84041 United States

  • Investigational Site 169

    Provo, Utah 84601 United States

  • Investigational Site 83

    Salt Lake City, Utah 84121 United States

  • Investigational Site 48

    West Jordan, Utah 84088 United States

  • Investigational Site 25

    South Burlington, Vermont 05403 United States

  • Investigational Site 1

    Richmond, Virginia 23233 United States

  • Investigational Site 24

    Richmond, Virginia 23294 United States

  • Investigational Site 3

    Springfield, Virginia 22152 United States

  • Investigational Site 89

    Bellingham, Washington 98225 United States

  • Investigational Site 71

    Puyallup, Washington 98371 United States

  • Investigational Site 44

    Seattle, Washington 98105 United States

  • Investigational Site 175

    Spokane, Washington 99204 United States

  • Investigational Site 68

    Spokane, Washington 99202 United States

  • Investigational Site 145

    Tacoma, Washington 98405 United States

  • Investigational Site 148

    Tacoma, Washington 98405 United States

  • Investigational Site 93

    Vancouver, Washington 98664 United States

  • Investigational Site 69

    Greenfield, Wisconsin 53228 United States

  • Investigational Site 8

    Madison, Wisconsin 53715 United States

  • Investigational Site 141

    Madison, Wisconsin 53792 United States

  • Investigational Site 146

    Milwuakee, Wisconsin 53226 United States

  • Investigational Site 9

    West Allis, Wisconsin 53227 United States

  • Investigational Site 300

    Brampton, L6T 0G1 Canada

  • Investigational Site 312

    Burlington, L7M 4Y1 Canada

  • Investigational Site 330

    Corunna, N0N 1G0 Canada

  • Investigational Site 321

    Etobicoke, M8V 3X8 Canada

  • Investigational Site 305

    Kanata, K2L 3C8 Canada

  • Investigational Site 324

    London, N6C 4Y7 Canada

  • Investigational Site 322

    London, N5W 6A2 Canada

  • Investigational Site 315

    London, N6A 5R8 Canada

  • Investigational Site 303

    Montreal, H3G 1L5 Canada

  • Investigational Site 317

    Montreal, G1W 4R4 Canada

  • Investigational Site 311

    Montreal, H2R 1V6 Canada

  • Investigational Site 327

    Montreal, H4N 2W2 Canada

  • Investigational Site 319

    Montreal, H4N 3C5 Canada

  • Investigational Site 323

    Newmarket, L3Y 5G8 Canada

  • Investigational Site 301

    Niagara Falls, L2G 1J4 Canada

  • Investigational Site 316

    Ottawa, K1Y 4G2 Canada

  • Investigational Site 308

    Quebec, G1V 4M6 Canada

  • Investigational Site 306

    Quebec, G1N 4V3 Canada

  • Investigational Site 325

    Saint John's, A1E 2E2 Canada

  • Investigational Site 302

    Saint-Romuald, G6W 5M6 Canada

  • Investigational Site 326

    Sarnia, N7T 4X3 Canada

  • Investigational Site 318

    Sherbrooke, J1H 1Z1 Canada

  • Investigational Site 314

    Toronto, M4V 1R2 Canada

  • Investigational Site 310

    Toronto, M9W 4L6 Canada

  • Investigational Site 307

    Toronto, M9V 4B4 Canada

  • Investigational Site 309

    Trois-Rivieres, G8T 7A1 Canada

advertisement
V2012.311.925.327
Disclaimer: The list and ratings above are for informational purposes only, and is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. The goal of the information is to provide you with a comprehensive view of all available treatments, but should not be construed to indicate that use of any one treatment is safe, appropriate, or effective for you. Decisions about use of a new treatment, or about a change in your current treatment plan, should be in consultation with your doctor or other healthcare professional.