VomitingPhase 2/3NCT06390787
The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics
A Phase 2/3 study testing Metoclopramide and Vitamin B6, Vitamin B6 and Ondansetron in people with Vomiting, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study investigates the effectiveness of combining vitamin B6 (pyridoxine) and metoclopramide compared to standard antiemetic treatments for managing nausea and vomiting. Through a prospective, randomized controlled trial involving adult patients with diverse causes of nausea and vomiting, we aim to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vomiting
- What is being tested?
- Metoclopramide and Vitamin B6, Vitamin B6 and Ondansetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIraq
- Study dates
- 30 Jan 2024to 21 Apr 2024
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patients with vomiting
Who cannot join
- Patients vitally unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Antiemetic Efficacy: A Randomized Trial of Vitamin B6 and Metoclopramide Combination Therapy Versus Traditional Regimens
This study investigates the effectiveness of combining vitamin B6 (pyridoxine) and metoclopramide compared to standard antiemetic treatments for managing nausea and vomiting. Through a prospective, randomized controlled trial involving adult patients with diverse causes of nausea and vomiting, we aim to evaluate the frequency, severity, and tolerability of the B6 and metoclopramide combination. By elucidating its comparative efficacy against established antiemetics, this research seeks to provide evidence-based guidance for clinicians in selecting optimal treatment regimens tailored to individual patient needs, ultimately enhancing the management of nausea and vomiting across various medical conditions.
Read the detailed description
Title: Investigating the Efficacy of B6 and Metoclopramide Combination Versus Alternative Antiemetics: A Clinical Trial Proposal
Introduction:
Nausea and vomiting are common symptoms across various medical conditions and can significantly impact patients' quality of life and treatment outcomes. While several antiemetic medications exist, finding the most effective regimen remains a clinical challenge. This proposal aims to investigate the efficacy of a combination therapy comprising vitamin B6 (pyridoxine) and metoclopramide compared to other antiemetics in managing nausea and vomiting.
Rationale:
Both vitamin B6 and metoclopramide have shown antiemetic properties through different mechanisms of action. However, the comparative efficacy of this combination therapy against other standard antiemetics remains largely unexplored. Understanding the relative effectiveness of this combination could provide valuable insights into optimizing antiemetic strategies, particularly in patients with chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other related conditions.
Objectives:
This prospective, randomized controlled trial aims to evaluate the efficacy of B6 and metoclopramide combination therapy compared to alternative antiemetic regimens in reducing the frequency and severity of nausea and vomiting episodes in adult patients. Additionally, the study seeks to assess the safety profile and tolerability of the combination therapy.
Conclusion:
By elucidating the comparative efficacy of B6 and metoclopramide combination therapy, this study endeavors to contribute to evidence-based decision-making in the management of nausea and vomiting. The findings could potentially guide clinicians in selecting the most appropriate antiemetic regimen tailored to individual patient needs, ultimately improving patient outcomes and quality of life.
- Conditions
- Vomiting
- Being tested
- Metoclopramide and Vitamin B6, Vitamin B6, Ondansetron, Metoclopramide
- Keywords
- Vomiting, B6 Vitamin, Metoclopramide, Zofran
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide and Vitamin B6Drug
Also called Vitamin B6 and Metoclopramide combination
We gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting.
Vitamin B6Drug
Also called Pyridoxine
We gave only vitamin B6 (pyridoxine) as a treatment for managing nausea and vomiting.
OndansetronDrug
Also called Zofran
We gave only Zofran as a treatment for managing nausea and vomiting.
MetoclopramideDrug
Also called Plasil
We gave only Metoclopramide as a treatment for managing nausea and vomiting.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide Group | Active comparator | This group of 50 patients with vomiting were given Metoclopramide only for vomiting. Receives: Drug: Metoclopramide |
| Zofran Group | Active comparator | This group of 50 patients with vomiting were given Zofran only for vomiting. Receives: Drug: Ondansetron |
| B6 and Metoclopramide Group | Experimental | This group of 50 patients with vomiting were given B6 and Metoclopramide combination for vomiting. Receives: Drug: Metoclopramide and Vitamin B6 |
| Control Group | No intervention | This group of 50 patients with vomiting were given nothing for vomiting. |
| Vitamin B6 Group | Active comparator | This group of 50 patients with vomiting were given Vitamin B6 only for vomiting. Receives: Drug: Vitamin B6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea
Four characteristics of nausea typically were measured including duration, frequency, severity, and associated distress. Duration was measured by asking the patient if they had experienced nausea and/or the number of hours that nausea was experienced during the time frame addressed.
Measured: 1 day
Vomiting
Four characteristics of vomiting typically were measured including duration, frequency, severity, and associated distress. Duration was measured by asking the patient if they had experienced vomiting and/or the number of hours that vomiing was experienced during the time frame addressed.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Jan 2024
- Primary completion20 Apr 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Talib Hashim, University of Baghdad
- Investigators
- Hashim Talib T Hashim, MBChB, Principal investigator, University of Warith Al-Anbiyaa, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390787
- Sponsor's protocol ID
- 007
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not sharing any individual data with anyone.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Antiemetic Efficacy: A Randomized Trial of Vitamin B6 and Metoclopramide Combination Therapy Versus Traditional Regimens
- ClinicalTrials.gov ID
- NCT06390787
- Acronym / sponsor ID
- 007
- Conditions
- Vomiting
- Keywords
- Vomiting, B6 Vitamin, Metoclopramide, Zofran
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 30 Apr 2024 (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.
This study investigates the effectiveness of combining vitamin B6 (pyridoxine) and metoclopramide compared to standard antiemetic treatments for managing nausea and vomiting. Through a prospective, randomized controlled trial involving adult patients with diverse causes of nausea and vomiting, we aim to evaluate the frequency, severity, and tolerability of the B6 and metoclopramide combination. By elucidating its comparative efficacy against established antiemetics, this research seeks to provide evidence-based guidance for clinicians in selecting optimal treatment regimens tailored to individual patient needs, ultimately enhancing the management of nausea and vomiting across various medical conditions.
Detailed description
Title: Investigating the Efficacy of B6 and Metoclopramide Combination Versus Alternative Antiemetics: A Clinical Trial Proposal
Introduction:
Nausea and vomiting are common symptoms across various medical conditions and can significantly impact patients' quality of life and treatment outcomes. While several antiemetic medications exist, finding the most effective regimen remains a clinical challenge. This proposal aims to investigate the efficacy of a combination therapy comprising vitamin B6 (pyridoxine) and metoclopramide compared to other antiemetics in managing nausea and vomiting.
Rationale:
Both vitamin B6 and metoclopramide have shown antiemetic properties through different mechanisms of action. However, the comparative efficacy of this combination therapy against other standard antiemetics remains largely unexplored. Understanding the relative effectiveness of this combination could provide valuable insights into optimizing antiemetic strategies, particularly in patients with chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other related conditions.
Objectives:
This prospective, randomized controlled trial aims to evaluate the efficacy of B6 and metoclopramide combination therapy compared to alternative antiemetic regimens in reducing the frequency and severity of nausea and vomiting episodes in adult patients. Additionally, the study seeks to assess the safety profile and tolerability of the combination therapy.
Conclusion:
By elucidating the comparative efficacy of B6 and metoclopramide combination therapy, this study endeavors to contribute to evidence-based decision-making in the management of nausea and vomiting. The findings could potentially guide clinicians in selecting the most appropriate antiemetic regimen tailored to individual patient needs, ultimately improving patient outcomes and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide Group | Active comparator | Drug: MetoclopramideThis group of 50 patients with vomiting were given Metoclopramide only for vomiting. |
| Zofran Group | Active comparator | Drug: OndansetronThis group of 50 patients with vomiting were given Zofran only for vomiting. |
| B6 and Metoclopramide Group | Experimental | Drug: Metoclopramide and Vitamin B6This group of 50 patients with vomiting were given B6 and Metoclopramide combination for vomiting. |
| Control Group | No intervention | –This group of 50 patients with vomiting were given nothing for vomiting. |
| Vitamin B6 Group | Active comparator | Drug: Vitamin B6This group of 50 patients with vomiting were given Vitamin B6 only for vomiting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patients with vomiting
Key exclusion criteria (1 listed)
- Patients vitally unstable
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 |
|---|---|---|
| Metoclopramide and Vitamin B6Also: Vitamin B6 and Metoclopramide combinationWe gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting. | Drug | B6 and Metoclopramide Group |
| Vitamin B6Also: PyridoxineWe gave only vitamin B6 (pyridoxine) as a treatment for managing nausea and vomiting. | Drug | Vitamin B6 Group |
| OndansetronAlso: ZofranWe gave only Zofran as a treatment for managing nausea and vomiting. | Drug | Zofran Group |
| MetoclopramideAlso: PlasilWe gave only Metoclopramide as a treatment for managing nausea and vomiting. | Drug | Metoclopramide Group |
Primary outcome
Nausea
Time frame: 1 day
Four characteristics of nausea typically were measured including duration, frequency, severity, and associated distress. Duration was measured by asking the patient if they had experienced nausea and/or the number of hours that nausea was experienced during the time frame addressed.
Vomiting
Time frame: 1 day
Four characteristics of vomiting typically were measured including duration, frequency, severity, and associated distress. Duration was measured by asking the patient if they had experienced vomiting and/or the number of hours that vomiing was experienced during the time frame addressed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No. We are not sharing any individual data with anyone.
Related trials for Vomiting
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Nausea With Vomiting Chemotherapy-Induced
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Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
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A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
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.
Hashim Talib T Hashim, MBChB principal investigator
University of Warith Al-Anbiyaa, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metoclopramide and Vitamin B6, Vitamin B6 and Ondansetron in people with Vomiting, run by University of Baghdad at 1 site in Iraq.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2024. 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 Iraq. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea (time frame: 1 day). The study lists 2 primary outcomes in all. 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 30 Apr 2024.