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CompletedNCT00450853Updated Jan 27, 2015

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

A Phase 2 interventional study of granisetron in Vomiting, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.

Read the detailed description

5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared.

02

Conditions studied

  • Vomiting

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Keywords

  • emesis
  • granisetron
  • pharmacokinetics
  • subcutaneous.
03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's enrollment of 31 is below the median of 107 across 935 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cancer patients receiving platinum-based chemotherapy
  • adequate bone marrow, hepatic and renal function, respectively defined by: platelets >100000/mm3 and absolute neutrophil count >1500/mm3; bilirubin, AST and ALT \<2 times x upper limit of normality; and creatinine \<1.5 mg/dl.
  • ECOG performance status \<2 and body mass index from 20-28 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Serious concomitant diseases, in the invesgator´s criteria
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Granisetron SC-Granisetron IV

    Granisetron SC followed by Granisetron IV

    Drug: granisetron

Interventions

  • Druggranisetron

    Granisetron SC followed by granisetron IV

    Also known as: Granisetron SC followed by granisetron IV

06

What researchers measure

Primary outcomes

  1. Bioavailability

    Time frame: Approximately 6 weeks

Secondary outcomes

  1. Safety

    Time frame: Approximately 6 weeks

07

Study locations

1 site
  • Clinica Universitaria de Navarra
    Pamplona, Navarra 31008, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00450853
Lead sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Responsible party
Jose Luis Perez Gracia (Main investigator, Clinica Universidad de Navarra, Universidad de Navarra) — Principal investigator
First posted
Mar 22, 2007
Start date
Apr 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Jan 27, 2015

Study contacts

Alfonso Gurpide
principal investigator · Oncology Department. Clinica Universitaria de Navarra

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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