Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Nausea Clinical Trial

Official title:

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01249001
• Other study ID #: 1000019462
• Status: Terminated
• Phase: Phase 2
• First received: November 23, 2010
• Last updated: April 18, 2017
• Start date: October 2010
• Est. completion date: September 28, 2016

Study information

• Verified date: April 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 28, 2016
• Est. primary completion date: September 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy
• Nausea
• Vomiting

Intervention

Drug:
• Oral Aprepitant
Subject will receive an oral suspension containing 125mg of Aprepitant
• Aprepitant
Subjects will receive a 125 mg Aprepitant capsule

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of the oral suspension relative to the capsule		6 weeks
Secondary	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	6 weeks
Secondary	Proportion of children with adverse effects attributable to aprepitant		6 weeks