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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 12, 2014
Last verified: August 2014
  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



Estimated Enrollment: 42
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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 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: August 12, 2014
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
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 Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 22, 2014