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Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

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ClinicalTrials.gov Identifier: NCT01249001
Recruitment Status : Terminated (lack of eligible participants to enrol)
First Posted : November 25, 2010
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Lee Dupuis, The Hospital for Sick Children

Brief 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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Chemotherapy Drug: Oral Aprepitant Drug: Aprepitant Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
Actual Study Start Date : October 2010
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : September 28, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Bioavailability of the oral suspension relative to the capsule [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Severity of chemotherapy-induced nausea and vomiting (CINV) [ Time Frame: 6 weeks ]
    Subject will be asked to record episodes of nausea and vomiting that occur during and immediately following each chemotherapy cycle studied

  2. Proportion of children with adverse effects attributable to aprepitant [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249001


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Lee Dupuis, RPh, MScPhm, ACPR, FCSH The Hospital for Sick Children, Toronto Canada

Responsible Party: Lee Dupuis, Pharmacy Clinical Manager, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01249001     History of Changes
Other Study ID Numbers: 1000019462
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Lee Dupuis, The Hospital for Sick Children:
pediatrics
nausea
vomiting
chemotherapy
antiemetic

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action