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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00642512
Other study ID # S175.3.102
Secondary ID
Status Completed
Phase Phase 3
First received March 21, 2008
Last updated March 31, 2008
Start date July 2003
Est. completion date July 2004

Study information

Verified date March 2008
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date July 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.

- Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:

1. a moderate-to-high emetogenic regimen, or

2. oxaliplatin at doses employed for treatment of colon cancer, or

3. the combination of AC [AdriamycinÃ’ (60 mg/m2) with cyclophosphamide (600 mg/m2)] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.

Exclusion Criteria:

- Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.

- Chemotherapy agents falling into the high (Level 5) classification during study.

- Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
dronabinol
10 - 20 mg
ondansetron
8 - 16 mg
dronabinol/ondansetron
10 - 20 mg/8 - 16 mg
placebo
placebo

Locations

Country Name City State
United States Site 950 Anaheim California
United States Site 951 Arlington Virginia
United States Site 902 Bismarck North Dakota
United States Site 932 Boynton Beach Florida
United States Site 910 Bronx New York
United States Site 948 Brooklyn New York
United States Site 953 Brooklyn New York
United States Site 918 Charleston South Carolina
United States Site 917 Chattanooga Tennessee
United States Site 939 Chattanooga Tennessee
United States Site 944 Columbus Ohio
United States Site 942 Fargo North Dakota
United States Site 916 Fergus Falls Minnesota
United States Site 925 Fountain Valley California
United States Site 913 Greenbrae California
United States Site 937 Greenwood Mississippi
United States Site 928 Harvey Illinois
United States Site 924 Hollywood Florida
United States Site 940 Lakeland Florida
United States Site 919 Little Silver New Jersey
United States Site 909 Los Angeles California
United States Site 922 Marietta Georgia
United States Site 904 Missoula Montana
United States Site 923 N. Charleston South Carolina
United States Site 921 New Port Richey Florida
United States Site 929 New Port Richey Florida
United States Site 934 Oklahoma City Oklahoma
United States Site 914 Orland Park Illinois
United States Site 933 Ormond Beach Florida
United States Site 931 Philadelphia Pennsylvania
United States Site 906 Pittsburgh Pennsylvania
United States Site 908 Pomona California
United States Site 943 Rancho Mirage California
United States Site 926 Skokie Illinois
United States Site 905 Southfield Michigan
United States Site 946 Springfield Illinois
United States Site 958 St. Louis Missouri
United States Site 956 Terre Haute Indiana
United States Site 915 Texarkana Texas
United States Site 970 Tucson Arizona
United States Site 949 Valhalla New York
United States Site 920 Voorhees New Jersey
United States Site 947 Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication. 5 days No
Secondary Complete responder rate (no vomiting/retching, intensity of nausea of = 30 mm on the VAS and no use of rescue medication) 5 days No
Secondary Presence or absence of nausea 5 days No
Secondary Episodes of vomiting and/or retching 5 days No
Secondary Duration of nausea and vomiting and/or retching 5 days No
See also
  Status Clinical Trial Phase
Recruiting NCT06065722 - Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy Phase 2
Completed NCT01362530 - A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208) Phase 3
Recruiting NCT02205164 - Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients Phase 2
Completed NCT01596400 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years Phase 1
Not yet recruiting NCT04873284 - Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients N/A
Recruiting NCT02097823 - Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy Phase 2
Completed NCT01402024 - Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy Phase 3
Completed NCT00211601 - Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041) N/A
Completed NCT05792228 - A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting N/A
Withdrawn NCT01596426 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years Phase 1
Withdrawn NCT01596413 - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years Phase 1