Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

November 27, 2019 updated by: Felipe Melo Cruz, Faculdade de Medicina do ABC

Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy.

All patients will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3.

Patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
  • 18 years or older;
  • Eastern Cooperative Oncology Group < 2

Exclusion Criteria:

  • Nausea or vomiting 24h before randomization
  • aspartate aminotransferase / alanine aminotransferase above 3 times the upper limit
  • Severe cognitive compromise;
  • regular use of corticosteroids, opioid, benzodiazepines, tricyclic antidepressant, or cannabinoids within 30 days before randomization;
  • brain metastasis;
  • chronic alcoholism;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin
Pregabalin 75mg, twice a day, from the night before chemotherapy to day 5
Drug: Pregabalin
antipsychotic
Other Names:
  • Lyrica
Experimental: Placebo
Placebo, twice a day, from the night before chemotherapy to day 5
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients achieving complete control of nausea and vomiting
Time Frame: five days
five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

February 28, 2020

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCC 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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