Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
This study is currently recruiting participants.
Verified February 2012 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01249001
First received: November 23, 2010
Last updated: February 22, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea Vomiting Chemotherapy |
Drug: Oral Aprepitant Drug: Aprepitant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents |
Resource links provided by NLM:
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- Bioavailability of the oral suspension relative to the capsule [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Severity of chemotherapy-induced nausea and vomiting (CINV) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Subject will be asked to record episodes of nausea and vomiting that occur during and immediately following each chemotherapy cycle studied
- Proportion of children with adverse effects attributable to aprepitant [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 22 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
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.
|
Drug: Oral Aprepitant
Subject will receive an oral suspension containing 125mg of Aprepitant
Other Name: Emend
Drug: Aprepitant
Subjects will receive a 125 mg Aprepitant capsule
Other Name: Emend
|
|
Experimental: Group 2
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.
|
Drug: Oral Aprepitant
Subject will receive an oral suspension containing 125mg of Aprepitant
Other Name: Emend
Drug: Aprepitant
Subjects will receive a 125 mg Aprepitant capsule
Other Name: Emend
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249001
Contacts
| Contact: Lee Dupuis, RPh, MScPhm, ACPR, FCSH | 416-813-6475 | lee.dupuis@sickkids.ca |
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Lee Dupuis, MD 416 813 6475 lee.dupuis@sickkids.ca | |
| Principal Investigator: Lee Dupuis, BSc, RPh, MScPhm, ACPR, FCSHP | |
| Sub-Investigator: Paul C Nathan, MD, MSc, FRCPC | |
| Sub-Investigator: Eleanor Hendershot, BScN, MN, NP-Peds | |
| Sub-Investigator: Sue Zupanee, MN, NP-Peds | |
| Sub-Investigator: Karen Lingertat-Walsh, RPh, BScPhm | |
| Sub-Investigator: Scott E. Walker, RPh, ACPR, MScPhm, FCSHP | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Lee Dupuis, RPh, MScPhm, ACPR, FCSH | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided
| Responsible Party: | Ms. Lee Dupuis / Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01249001 History of Changes |
| Other Study ID Numbers: | 1000019462 |
| Study First Received: | November 23, 2010 |
| Last Updated: | February 22, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
pediatrics nausea vomiting chemotherapy antiemetic |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Aprepitant Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013