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

February 2, 2011
May 12, 2016
July 2009
June 2015   (final data collection date for primary outcome measure)
  • 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

Same as current
Complete list of historical versions of study NCT01289938 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Drug Metabolism, Poor, CYP2D6-RELATED
  • Drug: Diphenhydramine
    Diphenhydramine 50 mg oral once
    Other Name: DPH
  • Drug: Metoclopramide
    10 mg i.v. metoclopramide once
    Other Name: MCP
  • Active Comparator: Metoclopramide
    Metoclopramide treatment
    Intervention: Drug: Metoclopramide
  • Active Comparator: Diphenhydramine
    Diphenhydramine treatment
    Intervention: Drug: Diphenhydramine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01289938
IKP231, 2008-003778-16
No
Not Provided
Not Provided
Matthias Schwab, University Hospital Tuebingen
Matthias Schwab
Not Provided
Principal Investigator: Matthias Schwab, MD UKT
University Hospital Tuebingen
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP