Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting

This study has been completed.

Sponsor:

Information provided by:

Shin Nippon Biomedical Laboratories, Ltd.

ClinicalTrials.gov Identifier:

NCT00787566

First received: November 5, 2008

Last updated: July 5, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 5, 2008
Last Updated Date	July 5, 2011
Start Date ^ICMJE	October 2008
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 24, 2011)	Percentage of Patients With Complete Control [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.
Original Primary Outcome Measures ^ICMJE (submitted: November 6, 2008)	To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00787566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 24, 2011)	Percentage of Patients With Complete Response [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Complete Response is defined as no emetic episodes and no use of rescue medications Percentage of Patients With Total Response [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications Percentage of Patients With Major Control of Emesis [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] Major Control of emesis = 2 emetic episodes Percentage of Patients With Minor Control of Emesis [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] Minor Control of emesis: 3-5 emetic episodes Percentage of Patients With Failure [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] Failure: > 5 emetic episodes Percentage of Patients Using Rescue Medications [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Time to First Emetic Episode [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Time to First Rescue Medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Time to Treatment Failure [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first Number of Emetic Episodes [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Severity of Nausea Measured by a 4 Categorical Scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ] 4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden) Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS [ Time Frame: 24 hours ] [ Designated as safety issue: No ] VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied
Original Secondary Outcome Measures ^ICMJE (submitted: November 6, 2008)	To evaluate the safety & tolerability of a single dose of TRG for the prevention of acute-onset (0-24 hours) CINV. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ] To evaluate the dose response of 3 doses of TRG for the prevention of acute-onset CINV. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
Official Title ^ICMJE	A Randomized, Single Administration, Double-blind, Parallel-group Phase 2 Dose Finding Study to Assess the Efficacy, Tolerability, and Safety of TRG (Intranasal Granisetron) in Patients With Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic Chemotherapy
Brief Summary	Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy. Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Chemotherapy-Induced Nausea and Vomiting
Intervention ^ICMJE	Drug: Intranasal granisetron 0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen Other Name: TRG
Study Arm (s)	Experimental: 0.5 mg of TRG (intranasal granisetron) 0.5 mg dose, intranasal powder, single spray, administered once Intervention: Drug: Intranasal granisetron Experimental: 1.0 mg of TRG (intranasal granisetron) 1.0 mg dose, intranasal powder, songle spray, administered once Intervention: Drug: Intranasal granisetron Experimental: 2.0 mg of TRG (intranasal granisetron) 2.0 mg dose, intranasal powder, single spray, administered once Intervention: Drug: Intranasal granisetron
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	68
Completion Date	May 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with histologically and/or cytologically confirmed cancer ECOG performance status of 0, 1, or 2 Patients with life expectancy of at least 3 months Patients who are chemotherapy naïve Patients who will be receiving the first cycle of a highly emetogenic regimen according to the MASCC criteria or the Hesketh criteria Patients with adequate metabolic or hematologic values for chemotherapy Patients with intact nasal mucosa Non child-bearing potential patients Patients able to read and write at a competent level, and capable of giving legal consent Patients who have provided written informed consent Exclusion Criteria: Patients who do not receive a chemotherapy regimen which is a highly emetogenic chemotherapy regimen according to the MASCC or the Hesketh criteria Patients with nasal cancers, pharyngeal cancers, maxillary sinus cancers, or ethmoid sinus cancers Patients with nasal ulcers, septal perforation, or other nasal conditions that may interfere with IN administration Patients with any episode of retching, vomiting, or uncontrolled nausea within 48 hours before dosing with TRG and/or administration of chemotherapy Patients who have received radiation therapy in the 14 days before dosing with TRG, or for whom radiation therapy is scheduled during the 7 days after a TRG dose Patients who have received any investigational product within 30 days prior to study entry Patients who have received any drug or who were scheduled to receive any drug with antiemetic efficacy within 24 hours of the start of treatment Patients who have an allergy or hypersensitivity to granisetron or other selective 5hydroxytryptamine3(5-HT3) receptor antagonists Patients with ECOG performance status of 3 or 4 Patients who have or have a history of brain tumors, head cancers, or neck cancers Patients who have a psychological problem that, in the Investigator's opinion, is severe enough to interfere with study eligibility or with interpretation of study results Patients who are pregnant (urine test) or breastfeeding Patients who have received prior cytotoxic chemotherapy given for the treatment of cancer Patients scheduled to receive multiple day chemotherapy Patients with clinically relevant abnormal laboratory values at the discretion of the Investigator Patients with clinically relevant hepatic, renal, infectious, neurological, or psychiatric disorders, or any other major systemic illness at the discretion of the Investigator Patients with any prevalence or cause of nausea and vomiting other than chemotherapy Patients using systemic steroids for any indication, or patients using steroids other than dexamethasone for prevention of chemotherapy-induced nausea and vomiting, or patients using dexamethasone for chemotherapy-induced nausea and vomiting at doses other than recommended in the MASCC antiemetic guidelines Patients with a QT interval greater than 500 ms or with acute ischemic changes or cardiac abnormality predisposing to arrhythmia on screening electrocardiogram (ECG) or by history Patients with a history of drug and/or alcohol abuse.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00787566
Other Study ID Numbers ^ICMJE	TRG-002
Has Data Monitoring Committee	Not Provided
Responsible Party	Vanaja Ragavan, MD, Aviana Consulting, LLC
Study Sponsor ^ICMJE	Shin Nippon Biomedical Laboratories, Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shin Nippon Biomedical Laboratories, Ltd.
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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