NauseaPhase 2NCT04181346
Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
A Phase 2 study testing Pregabalin in people with Nausea, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 28 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
- 18 years or older;
- Eastern Cooperative Oncology Group < 2
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
IBCC Oncologia
São Paulo, São Paulo, 03102002
Felipe Cruz, PhD, 5511981388214, felipemcruz@yahoo.com.br
Juliana Mauri, Dr, 5511981388214, julianamauri@ibcc.org.br
About this study
Official title: 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)
Read the 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.
- Conditions
- Nausea
- Being tested
- Pregabalin, Placebo
- Keywords
- pregabalin, nausea
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
antipsychotic
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Pregabalin 75mg, twice a day, from the night before chemotherapy to day 5 Receives: Drug: Pregabalin |
| Placebo | Experimental | Placebo, twice a day, from the night before chemotherapy to day 5 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving complete control of nausea and vomiting
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Sep 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy will be randomized for two arms: pregabalin and placebo. All patients received 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Melo Cruz, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181346
- Sponsor's protocol ID
- IBCC 01
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04181346
- Acronym / sponsor ID
- IBCC 01
- Conditions
- Nausea
- Keywords
- pregabalin, nausea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy will be randomized for two arms: pregabalin and placebo. All patients received 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.
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: PregabalinPregabalin 75mg, twice a day, from the night before chemotherapy to day 5 |
| Placebo | Experimental | Drug: PlaceboPlacebo, twice a day, from the night before chemotherapy to day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
- 18 years or older;
- Eastern Cooperative Oncology Group < 2
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: Lyricaantipsychotic | Drug | Pregabalin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage of patients achieving complete control of nausea and vomiting
Time frame: five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pregabalin in people with Nausea, run by Faculdade de Medicina do ABC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe Cruz, PhD (5511981388214, felipemcruz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving complete control of nausea and vomiting (time frame: five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.