NauseaPhase 2NCT01249001
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
A Phase 2 study testing Oral Aprepitant and Aprepitant in people with Nausea and Vomiting, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Nausea, Vomiting, Chemotherapy
- What is being tested?
- Oral Aprepitant and Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to 28 Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-18 years of age;
- able to swallow whole capsules;
- weighing ≥40kg;
- AST, ALT no more than 3 times the upper limit of normal for age and bilirubin concentrations within normal limits;
- receiving 2 consecutive (within 8 weeks) eligible, though not necessarily identical, IV chemotherapy cycles;
- English speaking (nausea assessment tool (PeNAT30) has been validated only in English)
- cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional (to permit self-assessment of nausea severity).
Who cannot join
- receiving very cisplatin containing chemotherapy (aprepitant capsule administration to these patients is the current standard of care at Sick Kids)
- receiving chemotherapy within 5 days before,during or 5 days after either study cycle that is known or suspected to interact with aprepitant; that is, cyclophosphamide, doxorubicin, daunomycin, etoposide, irinotecan, ifosfamide, imatinib, paclitaxel, topotecan, vinorelbine, vinblastine and vincristine;
- receiving medication known to interact with aprepitant other than dexamethasone (see Appendix I for list of applicable agents and timeframe for exclusion);
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.
Read the detailed description
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. In a recent survey, parents of children receiving chemotherapy in Ontario centres identified nausea as the fourth most prevalent and bothersome treatment-related symptom experienced by their children. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to children.
- Conditions
- Nausea, Vomiting, Chemotherapy
- Being tested
- Oral Aprepitant, Aprepitant
- Keywords
- pediatrics, nausea, vomiting, chemotherapy, antiemetic
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AprepitantDrug
Also called Emend
Subject will receive an oral suspension containing 125mg of Aprepitant
AprepitantDrug
Also called Emend
Subjects will receive a 125 mg Aprepitant capsule
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group will receive oral aprepitant on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the capsule on the first day of the second study cycle of chemotherapy. Receives: Drug: Oral Aprepitant; Drug: Aprepitant |
| Group 2 | Experimental | This group will receive an aprepitant capsule on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the oral aprepitant on the first day of the second study cycle of chemotherapy. Receives: Drug: Oral Aprepitant; Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of the oral suspension relative to the capsule
Measured: 6 weeks
Secondary outcomes (2)
Severity of chemotherapy-induced nausea and vomiting (CINV)
Subject will be asked to record episodes of nausea and vomiting that occur during and immediately following each chemotherapy cycle studied
Measured: 6 weeks
Proportion of children with adverse effects attributable to aprepitant
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startOct 2010
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Why it stopped: lack of eligible participants to enrol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Dupuis, The Hospital for Sick Children
- Investigators
- Lee Dupuis, RPh, MScPhm, ACPR, FCSH, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249001
- Sponsor's protocol ID
- 1000019462
- Status last verified
- Apr 2017
- First submitted
- 23 Nov 2010
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
- ClinicalTrials.gov ID
- NCT01249001
- Acronym / sponsor ID
- 1000019462
- Conditions
- Nausea, Vomiting, Chemotherapy
- Keywords
- pediatrics, nausea, vomiting, chemotherapy, antiemetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of eligible participants to enrol
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.
Detailed description
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. In a recent survey, parents of children receiving chemotherapy in Ontario centres identified nausea as the fourth most prevalent and bothersome treatment-related symptom experienced by their children. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Oral Aprepitant, Drug: AprepitantThis group will receive oral aprepitant on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the capsule on the first day of the second study cycle of chemotherapy. |
| Group 2 | Experimental | Drug: Oral Aprepitant, Drug: AprepitantThis group will receive an aprepitant capsule on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the oral aprepitant on the first day of the second study cycle of chemotherapy. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 12-18 years of age;
- able to swallow whole capsules;
- weighing ≥40kg;
- AST, ALT no more than 3 times the upper limit of normal for age and bilirubin concentrations within normal limits;
- receiving 2 consecutive (within 8 weeks) eligible, though not necessarily identical, IV chemotherapy cycles;
Key exclusion criteria (4 listed)
- receiving very cisplatin containing chemotherapy (aprepitant capsule administration to these patients is the current standard of care at Sick Kids)
- receiving chemotherapy within 5 days before,during or 5 days after either study cycle that is known or suspected to interact with aprepitant; that is, cyclophosphamide, doxorubicin, daunomycin, etoposide, irinotecan, ifosfamide, imatinib, paclitaxel, topotecan, vinorelbine, vinblastine and vincristine;
- receiving medication known to interact with aprepitant other than dexamethasone (see Appendix I for list of applicable agents and timeframe for exclusion);
- Pregnant or breastfeeding
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 |
|---|---|---|
| Oral AprepitantAlso: EmendSubject will receive an oral suspension containing 125mg of Aprepitant | Drug | Group 1, Group 2 |
| AprepitantAlso: EmendSubjects will receive a 125 mg Aprepitant capsule | Drug | Group 1, Group 2 |
Primary outcome
Bioavailability of the oral suspension relative to the capsule
Time frame: 6 weeks
2 secondary outcomes
Severity of chemotherapy-induced nausea and vomiting (CINV)
Time frame: 6 weeks
Proportion of children with adverse effects attributable to aprepitant
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: lack of eligible participants to enrol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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.
Lee Dupuis, RPh, MScPhm, ACPR, FCSH principal investigator
The Hospital for Sick Children, Toronto Canada
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 Oral Aprepitant and Aprepitant in people with Nausea and Vomiting, run by The Hospital for Sick Children at 1 site in Canada.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Apr 2017. 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 Canada. 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?
The study was stopped early (reason given: lack of eligible participants to enrol). Results are not available in the source record.
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?
Bioavailability of the oral suspension relative to the capsule (time frame: 6 weeks). 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 19 Apr 2017.