Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine (MalD)

May 12, 2016 updated by: Matthias Schwab
Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72076
        • Abteilung Klinische Pharmakologie, UKT Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Metoclopramide
Metoclopramide treatment
Drug: Metoclopramide
10 mg i.v. metoclopramide once
Other Names:
  • MCP
ACTIVE_COMPARATOR: Diphenhydramine
Diphenhydramine treatment
Drug: Diphenhydramine
Diphenhydramine 50 mg oral once
Other Names:
  • DPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve of metoclopramide (MCP)
Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Pharmacokinetic of MCP at following time points:

0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Area under curve of diphenhydramine(DPH)
Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Pharmacokinetics of DPH at following time points:

0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of metoclopramide
Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Cmax of metoclopramide at following time points:

0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Tmax of metoclopramide
Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Tmax of metoclopramide at following time points:

0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Cmax of diphenhydramine
Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Cmax of diphenhydramine at the following time points:

0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Tmax of diphenhydramine
Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Tmax of diphenhydramine at the following time points:

0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthias Schwab

Investigators

  • Principal Investigator: Matthias Schwab, MD, UKT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (ESTIMATE)

February 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKP231
  • 2008-003778-16 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe