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

NCT06390787 | Completed Phase 2 DMC

• 1 other identifier: 007
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Vomiting

Keywords

Vomiting; B6 Vitamin; Metoclopramide; Zofran

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

Metoclopramide Group

ACTIVE COMPARATOR

This group of 50 patients with vomiting were given Metoclopramide only for vomiting.

Drug: Metoclopramide

Zofran Group

ACTIVE COMPARATOR

This group of 50 patients with vomiting were given Zofran only for vomiting.

Drug: Ondansetron

B6 and Metoclopramide Group

EXPERIMENTAL

This group of 50 patients with vomiting were given B6 and Metoclopramide combination for vomiting.

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.

Drug: Vitamin B6

Interventions

Metoclopramide and Vitamin B6 DRUG

We gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting.

Also known as: Vitamin B6 and Metoclopramide combination

B6 and Metoclopramide Group

Vitamin B6 DRUG

We gave only vitamin B6 (pyridoxine) as a treatment for managing nausea and vomiting.

Also known as: Pyridoxine

Vitamin B6 Group

Ondansetron DRUG

We gave only Zofran as a treatment for managing nausea and vomiting.

Also known as: Zofran

Zofran Group

Metoclopramide DRUG

We gave only Metoclopramide as a treatment for managing nausea and vomiting.

Also known as: Plasil

Metoclopramide Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patients with vomiting

You may not qualify if:

• Patients vitally unstable

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Al-Nassiryah Teaching Hospital

Nasiriyah, Thi Qar, 64001, Iraq

Location

MeSH Terms

Conditions

Vomiting

Interventions

Metoclopramide; Vitamin B 6; Pyridoxine; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Hashim Talib T Hashim, MBChB

  University of Warith Al-Anbiyaa, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 30, 2024
• Study Start: January 30, 2024
• Primary Completion: April 20, 2024
• Study Completion: April 21, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)