Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

NCT ID: NCT01289938

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Metabolism, Poor, CYP2D6-RELATED

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metoclopramide

Metoclopramide treatment

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

10 mg i.v. metoclopramide once

Diphenhydramine

Diphenhydramine treatment

Group Type ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type DRUG

Diphenhydramine 50 mg oral once

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diphenhydramine

Diphenhydramine 50 mg oral once

Intervention Type DRUG

Metoclopramide

10 mg i.v. metoclopramide once

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DPH MCP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI 20 - 27kg/m2
* Caucasians
* Healthy volunteers

Exclusion Criteria

* Pregnancy/lactation period
* Drug allergy
* Acute and chronic diseases
* Taking medication
* Abuse of drugs, alcohol etc.
* Smoker
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Matthias Schwab

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matthias Schwab

Prof. M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthias Schwab, MD

Role: PRINCIPAL_INVESTIGATOR

UKT

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Abteilung Klinische Pharmakologie, UKT Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta. 2007 Mar;1770(3):489-94. doi: 10.1016/j.bbagen.2006.09.019. Epub 2006 Oct 4.

Reference Type BACKGROUND
PMID: 17113714 (View on PubMed)

Schroth W, Antoniadou L, Fritz P, Schwab M, Muerdter T, Zanger UM, Simon W, Eichelbaum M, Brauch H. Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J Clin Oncol. 2007 Nov 20;25(33):5187-93. doi: 10.1200/JCO.2007.12.2705.

Reference Type BACKGROUND
PMID: 18024866 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-003778-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IKP231

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Narcotic-Induced Nausea
NCT00541671 TERMINATED NA