The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics

Vomiting Clinical Trial

Official title:

Enhancing Antiemetic Efficacy: A Randomized Trial of Vitamin B6 and Metoclopramide Combination Therapy Versus Traditional Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06390787
• Other study ID #: 007
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 30, 2024
• Est. completion date: April 21, 2024

Study information

• Verified date: April 2024
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 21, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Any patients with vomiting

Exclusion Criteria:

• Patients vitally unstable

Related Conditions & MeSH terms

• Vomiting

Intervention

Drug:
• Metoclopramide and Vitamin B6
We gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting.
• Vitamin B6
We gave only vitamin B6 (pyridoxine) as a treatment for managing nausea and vomiting.
• Ondansetron
We gave only Zofran as a treatment for managing nausea and vomiting.
• Metoclopramide
We gave only Metoclopramide as a treatment for managing nausea and vomiting.

Locations

Country	Name	City	State
Iraq	Al-Nassiryah Teaching Hospital	Nasiriyah	Thi Qar

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	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.	1 day