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

This study has been terminated.
(To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).)
Sponsor:
Information provided by (Responsible Party):
Matthias Schwab, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01289938
First received: February 2, 2011
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Drug Metabolism, Poor, CYP2D6-RELATED
Drug: Diphenhydramine
Drug: Metoclopramide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Area under curve of metoclopramide (MCP) [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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


  • Area under curve of diphenhydramine(DPH) [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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:
  • Cmax of metoclopramide [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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


  • Tmax of metoclopramide [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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


  • Cmax of diphenhydramine [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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


  • Tmax of diphenhydramine [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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



Enrollment: 49
Study Start Date: July 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 2, 2011
Last Updated: May 12, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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

ClinicalTrials.gov processed this record on December 02, 2016