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. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

NCT00169572.

Methods Randomised, phase 2, parallel‐assignment study
Study start date: February 2005
Study completion date: not provided
  • number of enrolled subjects: 492


Masking: double‐blind
Baseline patient characteristics: n.r.
Participants Inclusion criteria
  • willing to provide written informed consent before receiving any study‐specific procedures or assessments

  • diagnosed solid malignant tumour

  • has not previously received chemotherapy

  • scheduled to receive chemotherapy conducive to regimens outlined in the study protocol


Exclusion criteria
  • has not received any investigational product within 30 days of enrolment into the study

  • must not be pregnant

  • must not be of child‐bearing potential or willing to use specific barrier methods outlined in the protocol

  • must not be scheduled to receive radiation therapy to abdomen or pelvis within seven (7) days before the start of study medication

  • must not be currently under treatment for a condition that may cause nausea or vomiting (e.g. active peptic ulcer disease, gastric obstruction)

  • must not have a history of peptic ulcer disease


Mean/median age, years: n.r.
Gender: male + female
Tumour/cancer type: solid malignancy
Chemotherapy regimen: n.r.
Country: Argentina, Austria, Belgium, Chile, Croatia, Czech Republic, Hong Kong, Hungary, Italy, Mexico, Netherlands, Pakistan, Peru, Philippines, Poland, Romania, Singapore, Slovakia, Taiwan
Interventions Drug: aprepitant, ondansetron, GW679769, dexamethasone
Study arms: not provided
Outcomes Primary outcome
  • number of subjects who do not experience vomiting, retching, or nausea over a 5‐day period following initiation of chemotherapy


Secondary outcomes
  • routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, adverse events reporting

Notes
  • ClinicalTrials.gov identifier (NCT number): NCT00169572

  • sponsors and collaborators: GlaxoSmithKline