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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01289938
Recruitment Status : Terminated (To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).)
First Posted : February 4, 2011
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6

Condition or disease Intervention/treatment Phase
Drug Metabolism, Poor, CYP2D6-RELATED Drug: Diphenhydramine Drug: Metoclopramide Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Study Start Date : July 2009
Primary Completion Date : June 2015
Study Completion Date : June 2015


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Metoclopramide
Metoclopramide treatment
Drug: Metoclopramide
10 mg i.v. metoclopramide once
Other Name: MCP
Active Comparator: Diphenhydramine
Diphenhydramine treatment
Drug: Diphenhydramine
Diphenhydramine 50 mg oral once
Other Name: DPH


Outcome Measures

Primary Outcome Measures :
  1. 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


  2. 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



Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289938


Locations
Germany
Abteilung Klinische Pharmakologie, UKT Tübingen
Tübingen, BW, Germany, 72076
Sponsors and Collaborators
Matthias Schwab
Investigators
Principal Investigator: Matthias Schwab, MD UKT
More Information

Publications:
Responsible Party: Matthias Schwab, Prof. M.D., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01289938     History of Changes
Other Study ID Numbers: IKP231
2008-003778-16 ( EudraCT Number )
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Matthias Schwab, University Hospital Tuebingen:
pharmacokinetic
pharmacogenetic
Metoclopramide
Diphenhydramine
CYP2D6 polymorphisms

Additional relevant MeSH terms:
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Diphenhydramine
Metoclopramide
Promethazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents