UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011323
Receipt number R000013269
Scientific Title Relationships between pharmacokinetics, antiemetic effect and adverse effect of prochlorperazine
Date of disclosure of the study information 2013/07/31
Last modified on 2014/02/20 21:47:14

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Basic information

Public title

Relationships between pharmacokinetics, antiemetic effect and adverse effect of prochlorperazine

Acronym

Relationships between pharmacokinetics, antiemetic effect and adverse effect of prochlorperazine

Scientific Title

Relationships between pharmacokinetics, antiemetic effect and adverse effect of prochlorperazine

Scientific Title:Acronym

Relationships between pharmacokinetics, antiemetic effect and adverse effect of prochlorperazine

Region

Japan


Condition

Condition

cancer

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the clinical responses to prochlorperazine based on non-genetic and genetic factors in cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Impact of plasma prochlorperazine concentrations and gene polymorphisms on antiemetic effect and serum prolactin level

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cancer patients receiving oral prochlorperazine for the prevention of opioid-induced nausea and vomiting

Key exclusion criteria

Patients who (1) discontinued oral prochlorperazine or opioid analgesics during the study; (2) were being co-treated with anticancer drugs; (3) were being co-treated with other dopamine receptor D2 antagonists; (4) were being co-treated with triazole antifungal agents, rifampin, or macrolide antibiotics; (5) were diagnosed as having prolactin-producing adenoma or brain tumors; and (6) were difficult to evaluate with respect to nausea and vomiting.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Kawakami

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital Pharmacy

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Masaki Tashiro

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital Pharmacy

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Hospital Pharmacy, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Hospital Pharmacy, Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

A higher incidence of nausea was observed in patients with DRD2 TaqIA A1.
Female gender altered the incidence of vomiting.
Plasma exposure of prochlorperazine affected serum prolactin concentration.
Patients with OPRM1 118A had a higher serum prolactin concentration.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry

2013 Year 12 Month 01 Day

Date trial data considered complete


Date analysis concluded

2014 Year 01 Month 01 Day


Other

Other related information

Imapacts of plasma prochlorperazine concentrations and gene polymorphisms on antiemetic effect and serum prolactin level


Management information

Registered date

2013 Year 07 Month 30 Day

Last modified on

2014 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013269


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name