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

Phase 2

Completed

• Conditions: Vomiting
• Interventions: Drug: Metoclopramide; Drug: Ondansetron; Drug: Metoclopramide and Vitamin B6; Drug: Vitamin B6

• Registration Number: NCT06390787
• Lead Sponsor: University of Baghdad

Brief 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.

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 Timeline

• Study Start: 2024-01-30
• Status Verified: 2024-04
• Primary Completion: 2024-04-20
• Study Completion: 2024-04-21
• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Any patients with vomiting

Exclusion Criteria

• Patients vitally unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide Group	Metoclopramide	This group of 50 patients with vomiting were given Metoclopramide only for vomiting.
Zofran Group	Ondansetron	This group of 50 patients with vomiting were given Zofran only for vomiting.
B6 and Metoclopramide Group	Metoclopramide and Vitamin B6	This group of 50 patients with vomiting were given B6 and Metoclopramide combination for vomiting.
Vitamin B6 Group	Vitamin B6	This group of 50 patients with vomiting were given Vitamin B6 only for vomiting.

Primary Outcome Measures

Name	Time	Method
Nausea	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	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.

Trial Locations

Locations (1)

Al-Nassiryah Teaching Hospital; 🇮🇶 Nasiriyah, Thi Qar, Iraq