Pharmacokinetics of Misoprostol With Titrated Oral Administration

NCT ID: NCT01271257

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

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The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.

Detailed Description

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The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.

Conditions

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Hypotonic; Labor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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hourly misoprostol

20 microgram misoprostol intake per hour

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses

traditional misoprostol

80 microgram misoprostol intake per 4 hours

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses

Interventions

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Misoprostol

20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses

Intervention Type DRUG

Other Intervention Names

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cytotec

Eligibility Criteria

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Inclusion Criteria

* 20-40 Y/O healthy and non-pregnant woman

Exclusion Criteria

* heart, liver or kidney disease, anaphylaxis to misoprostol
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi-Yann Cheng

Director of Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shi-Yann Cheng, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Beigang Hospital

Locations

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China Medical University Beigang Hospital

Yunlin Xian, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.

Reference Type BACKGROUND
PMID: 11821273 (View on PubMed)

Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.

Reference Type BACKGROUND
PMID: 9207820 (View on PubMed)

Related Links

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http://www.bh.cmu.edu.tw/cmubh/ch/index.php

China Medical University Beigang Hospital

Other Identifiers

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DMR-IRB-242

Identifier Type: OTHER

Identifier Source: secondary_id

CMUBH R990011

Identifier Type: -

Identifier Source: org_study_id

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