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Nausea And Vomiting |
Vomiting |
Clinical Trial: Prevention of Chemotherapy-induced Nausea and Vomiting
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be performed on study Day 20-30, at which time the subject will complete the study.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Nausea Vomiting Cancer | Drug: Investigational Antiemetic Drug | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Nausea and Vomiting
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Candidate is willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Candidate is scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
- Candidate is diagnosed with a solid malignant tumor, and has not previously received chemotherapy.
- Candidate is either not of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
Exclusion Criteria:
- Received any investigational product within 30 days of enrollment into the study.
- Candidate is pregnant.
- Candidate is scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- Candidate is currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
- Candidate has a history of peptic ulcer disease.
Location and Contact Information
Alabama
Birmingham, Alabama, 35209, United States; Recruiting
Study Coordinator 205-877-2985
California
Los Angeles, California, 90057, United States; Recruiting
Study Coordinator 213-989-1892
Palm Springs, California, 92262, United States; Recruiting
Study Coordinator 760-416-4734
Corona, California, 92882, United States; Recruiting
Study Coordinator 714-210-2300
Greenbrae, California, 94904, United States; Recruiting
Study Coordinator 415-925-5040
Colorado
Lakewood, Colorado, 80214, United States; Recruiting
Study Coordinator 303-232-0602 Ext. 37
Florida
Miami, Florida, 33161, United States; Recruiting
Study Coordinator 305-759-0888
Boynton Beach, Florida, 33435, United States; Recruiting
Study Coordinator 561-374-5020
Ocala, Florida, 34474, United States; Recruiting
Study Coordinator 352-732-4039
New Port Richey, Florida, 34652, United States; Recruiting
Study Coordinator 727-843-9841 Ext. 143
Illinois
Skokie, Illinois, 60076, United States; Recruiting
Study Coordinator 847-673-1999
Joliet, Illinois, 60435, United States; Recruiting
Study Coordinator 815-730-3033 Ext. 330
Centralia, Illinois, 62801, United States; Recruiting
Study Coordinator 618-533-5000
Indiana
New Albany, Indiana, 47150, United States; Recruiting
Study Coordinator 812-945-4000 Ext. 113
Muncie, Indiana, 47303, United States; Recruiting
Study Coordinator 765-281-2107
Evansville, Indiana, 47713, United States; Recruiting
Study Coordinator 812-426-9307
Louisiana
Baton Rouge, Louisiana, 70809, United States; Recruiting
Study Coordinator 225-757-0343
Alexandria, Louisiana, 71301, United States; Recruiting
Study Coordinator 318-448-6976
Maryland
Bethesda, Maryland, 20817, United States; Recruiting
Study Coordinator 301-571-2016
Massachusetts
Worcester, Massachusetts, 01605, United States; Recruiting
Study Coordinator 508-595-2212 Ext. 62212
Michigan
Bay City, Michigan, 48706, United States; Recruiting
Study Coordinator 989-667-6257
Mississippi
Tupelo, Mississippi, 38801, United States; Recruiting
Study Coordinator 662-844-9166
Missouri
St. Louis, Missouri, 63141, United States; Recruiting
Study Coordinator 314-251-7059
Jefferson City, Missouri, 65109, United States; Recruiting
Study Coordinator 573-893-6404
Rolla, Missouri, 65401, United States; Recruiting
Study Coordinator 573-364-8823 Ext. 282
New Jersey
Sparta, New Jersey, 07871, United States; Recruiting
Study Coordinator 973-726-0005
North Dakota
Bismark, North Dakota, 85803, United States; Recruiting
Study Coordinator 701-530-6960
Ohio
Akron, Ohio, 44304, United States; Recruiting
Study Coordinator 330-375-4221
Canton, Ohio, 44718, United States; Recruiting
Study Coordinator 330-492-3345 Ext. 208
South Carolina
Sumter, South Carolina, 29150, United States; Recruiting
Study Coordinator 803-934-8833
Texas
Dallas, Texas, 75237, United States; Recruiting
Study Coordinator 972-283-2389 Ext. 247
Houston, Texas, 77024, United States; Recruiting
Study Coordinator 713-827-7062 Ext. 206
Corpus Christi, Texas, 78463, United States; Recruiting
Study Coordinator 361-232-0610
Utah
West Point, Utah, 84341, United States; Recruiting
Study Coordinator 801-455-2854
Ogden, Utah, 84403, United States; Recruiting
Study Coordinator 801-387-7166
Vermont
Burlington, Vermont, 05401, United States; Recruiting
Study Coordinator 802-656-9924
Virginia
Richmond, Virginia, 23230, United States; Recruiting
Study Coordinator 804-288-7159
Abingdon, Virginia, 24211, United States; Recruiting
Study Coordinator 276-676-1863
Wisconsin
Rhinelander, Wisconsin, 54501, United States; Recruiting
Study Coordinator 715-361-4714
More Information
Study ID Numbers: NKV101983
Record last reviewed: February 2005
Last Updated: February 28, 2005
Record first received: February 28, 2005
ClinicalTrials.gov Identifier: NCT00104403
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2005
Last Updated: February 28, 2005
Record first received: February 28, 2005
ClinicalTrials.gov Identifier: NCT00104403
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- About Nausea and Vomiting (Cleveland Clinic)
- Childhood Vomiting and Nausea (HealthWorld)
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