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

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.

Study Overview

• Status: Completed
• Conditions: Vomiting
• Intervention / Treatment: Drug: Metoclopramide; Drug: Ondansetron; Drug: Metoclopramide and Vitamin B6; Drug: Vitamin B6

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iraq
  • Thi Qar
    • Nasiriyah, Thi Qar, Iraq, 64001
      • Al-Nassiryah Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patients with vomiting

Exclusion Criteria:

• Patients vitally unstable

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metoclopramide Group; This group of 50 patients with vomiting were given Metoclopramide only for vomiting.	Drug: Metoclopramide; We gave only Metoclopramide as a treatment for managing nausea and vomiting.; Other Names: Plasil
Active Comparator: Zofran Group; This group of 50 patients with vomiting were given Zofran only for vomiting.	Drug: Ondansetron; We gave only Zofran as a treatment for managing nausea and vomiting.; Other Names: Zofran
Experimental: B6 and Metoclopramide Group; This group of 50 patients with vomiting were given B6 and Metoclopramide combination for vomiting.	Drug: Metoclopramide and Vitamin B6; We gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting.; Other Names: Vitamin B6 and Metoclopramide combination
No Intervention: Control Group; This group of 50 patients with vomiting were given nothing for vomiting.
Active Comparator: Vitamin B6 Group; This group of 50 patients with vomiting were given Vitamin B6 only for vomiting.	Drug: Vitamin B6; We gave only vitamin B6 (pyridoxine) as a treatment for managing nausea and vomiting.; Other Names: Pyridoxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Hashim Talib T Hashim, MBChB, University of Warith Al-Anbiyaa, College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): April 21, 2024

Study Registration Dates

• First Submitted: April 21, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Vomiting; Metoclopramide; Zofran; B6 Vitamin
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Micronutrients; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Vitamins; Vitamin B Complex; Ondansetron; Vitamin B 6; Pyridoxal; Pyridoxine; Metoclopramide
• Other Study ID Numbers: 007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not sharing any individual data with anyone.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No