Chemotherapy-Induced Nausea and VomitingPhase 2NCT00787566
Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
A Phase 2 study testing Intranasal granisetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Shin Nippon Biomedical Laboratories, Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- Intranasal granisetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The study is conducted at 14 Centers, in 14 cities accross the United States
The Study Is Managed by Kendle International, in Wilmington, North Carolina, 28405
About this study
Official title: 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: 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.
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Being tested
- Intranasal granisetron
- Keywords
- Highly emetogenic chemotherapy induced nausea and vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal granisetronDrug
Also called TRG
0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg of TRG (intranasal granisetron) | Experimental | 0.5 mg dose, intranasal powder, single spray, administered once Receives: Drug: Intranasal granisetron |
| 1.0 mg of TRG (intranasal granisetron) | Experimental | 1.0 mg dose, intranasal powder, songle spray, administered once Receives: Drug: Intranasal granisetron |
| 2.0 mg of TRG (intranasal granisetron) | Experimental | 2.0 mg dose, intranasal powder, single spray, administered once Receives: Drug: Intranasal granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Complete Control
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.
Measured: 24 hours
Secondary outcomes (12)
Percentage of Patients With Complete Response
Complete Response is defined as no emetic episodes and no use of rescue medications
Measured: 24 hours
Percentage of Patients With Total Response
Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications
Measured: 24 hours
Percentage of Patients With Major Control of Emesis
Major Control of emesis = 2 emetic episodes
Measured: 24 hrs
Percentage of Patients With Minor Control of Emesis
Minor Control of emesis: 3-5 emetic episodes
Measured: 24 hrs
Percentage of Patients With Failure
Failure: > 5 emetic episodes
Measured: 24 hrs
Percentage of Patients Using Rescue Medications
Measured: 24 hours
Time to First Emetic Episode
Measured: 24 hours
Time to First Rescue Medication
Measured: 24 hours
Time to Treatment Failure
Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first
Measured: 24 hours
Number of Emetic Episodes
Measured: 24 hours
Severity of Nausea Measured by a 4 Categorical Scale
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)
Measured: 24 hours
Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS
VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Nippon Biomedical Laboratories, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787566
- Sponsor's protocol ID
- TRG-002
- Status last verified
- Jul 2011
- First submitted
- 5 Nov 2008
- Last updated
- 12 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00787566
- Acronym / sponsor ID
- TRG-002
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Keywords
- Highly emetogenic chemotherapy induced nausea and vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shin Nippon Biomedical Laboratories, Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 21 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg of TRG (intranasal granisetron) | Experimental | Drug: Intranasal granisetron0.5 mg dose, intranasal powder, single spray, administered once |
| 1.0 mg of TRG (intranasal granisetron) | Experimental | Drug: Intranasal granisetron1.0 mg dose, intranasal powder, songle spray, administered once |
| 2.0 mg of TRG (intranasal granisetron) | Experimental | Drug: Intranasal granisetron2.0 mg dose, intranasal powder, single spray, administered once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal granisetronAlso: TRG0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen | Drug | 0.5 mg of TRG (intranasal granisetron), 1.0 mg of TRG (intranasal granisetron), 2.0 mg of TRG (intranasal granisetron) |
Primary outcome
Percentage of Patients With Complete Control
Time frame: 24 hours
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.
12 secondary outcomes
Percentage of Patients With Complete Response
Time frame: 24 hours
Percentage of Patients With Total Response
Time frame: 24 hours
Percentage of Patients With Major Control of Emesis
Time frame: 24 hrs
Percentage of Patients With Minor Control of Emesis
Time frame: 24 hrs
Percentage of Patients With Failure
Time frame: 24 hrs
Percentage of Patients Using Rescue Medications
Time frame: 24 hours
Time to First Emetic Episode
Time frame: 24 hours
Time to First Rescue Medication
Time frame: 24 hours
Time to Treatment Failure
Time frame: 24 hours
Number of Emetic Episodes
Time frame: 24 hours
Severity of Nausea Measured by a 4 Categorical Scale
Time frame: 24 hours
Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal granisetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Shin Nippon Biomedical Laboratories, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Complete Control (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.