Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Lee Dupuis, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01249001
First received: November 23, 2010
Last updated: December 13, 2013
Last verified: December 2013
  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: March 2015
Estimated Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Lee Dupuis, Pharmacy Clinical Manager, 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: December 13, 2013
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 July 29, 2014