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

This study is currently recruiting participants.
Verified January 2013 by University Hospital Tuebingen
Sponsor:
Information provided by (Responsible Party):
Matthias Schwab, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01289938
First received: February 2, 2011
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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



Estimated Enrollment: 42
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289938

Locations
Germany
Abteilung Klinische Pharmakologie, UKT Tübingen Recruiting
Tübingen, BW, Germany, 72076
Contact: Matthias Schwab, Prof.     0049(0)71181013700     matthias.schwab@ikp-stuttgart.de    
Contact: Gabriele Böhmer, MD     0049(0)70712972269     gabriele.boehmer@med.uni-tuebingen.de    
Sub-Investigator: Gabriele Böhmer, MD            
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: January 31, 2013
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:
Diphenhydramine
Metoclopramide
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 22, 2013