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Pharmacokinetics of Misoprostol With Titrated Oral Administration

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ClinicalTrials.gov Identifier: NCT01271257
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Shi-Yann Cheng, China Medical University Hospital

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

Condition or disease Intervention/treatment Phase
Hypotonic; Labor Drug: Misoprostol Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 Study of Titrated Oral Misoprostol
Study Start Date : January 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: hourly misoprostol
20 microgram misoprostol intake per hour
Drug: Misoprostol
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other Name: cytotec

Active Comparator: traditional misoprostol
80 microgram misoprostol intake per 4 hours
Drug: Misoprostol
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other Name: cytotec




Primary Outcome Measures :
  1. AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes) [ Time Frame: 480 min post start of oral misoprostol administration ]

Secondary Outcome Measures :
  1. AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes) [ Time Frame: 240 min post start of oral misoprostol administration ]
  2. AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes) [ Time Frame: 360 min post start of oral misoprostol administration ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • heart, liver or kidney disease, anaphylaxis to misoprostol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271257


Locations
Taiwan
China Medical University Beigang Hospital
Yunlin Xian, Taiwan, 651
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Shi-Yann Cheng, M.D. China Medical University Beigang Hospital

Additional Information:
Publications:
Responsible Party: Shi-Yann Cheng, Director of Department of Obstetrics and Gynecology, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01271257     History of Changes
Other Study ID Numbers: CMUBH R990011
DMR-IRB-242 ( Other Identifier: China Medical University Hospital )
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Shi-Yann Cheng, China Medical University Hospital:
misoprostol, pharmacokinetics

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics