Study Stopped
To unsuccessful recruitment of rare UM-genotype. All other planned genotype groups are completed (EM, IM and PM).
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
MalD
2 other identifiers
interventional
49
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 13, 2016
May 1, 2016
5.9 years
February 2, 2011
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under curve of metoclopramide (MCP)
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
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Area under curve of diphenhydramine(DPH)
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
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Secondary Outcomes (4)
Cmax of metoclopramide
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Tmax of metoclopramide
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Cmax of diphenhydramine
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Tmax of diphenhydramine
0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Study Arms (2)
Metoclopramide
ACTIVE COMPARATORMetoclopramide treatment
Diphenhydramine
ACTIVE COMPARATORDiphenhydramine treatment
Interventions
Eligibility Criteria
You may qualify if:
- BMI 20 - 27kg/m2
- Caucasians
- Healthy volunteers
You may not qualify if:
- Pregnancy/lactation period
- Drug allergy
- Acute and chronic diseases
- Taking medication
- Abuse of drugs, alcohol etc.
- Smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Matthias Schwablead
Study Sites (1)
Abteilung Klinische Pharmakologie, UKT Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Related Publications (2)
Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta. 2007 Mar;1770(3):489-94. doi: 10.1016/j.bbagen.2006.09.019. Epub 2006 Oct 4.
PMID: 17113714BACKGROUNDSchroth W, Antoniadou L, Fritz P, Schwab M, Muerdter T, Zanger UM, Simon W, Eichelbaum M, Brauch H. Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J Clin Oncol. 2007 Nov 20;25(33):5187-93. doi: 10.1200/JCO.2007.12.2705.
PMID: 18024866BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias Schwab, MD
UKT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. M.D.
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 4, 2011
Study Start
July 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 13, 2016
Record last verified: 2016-05