Hypotonic; LaborPhase 1NCT01271257
Pharmacokinetics of Misoprostol With Titrated Oral Administration
A Phase 1 study testing Misoprostol in people with Hypotonic; Labor, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotonic; Labor
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 Y/O healthy and non-pregnant woman
Who cannot join
- heart, liver or kidney disease, anaphylaxis to misoprostol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Beigang Hospital
Yunlin Xian, Taiwan, 651
About this study
Official title: Phase 1 Study of Titrated Oral Misoprostol
The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.
Read the 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.
- Conditions
- Hypotonic; Labor
- Being tested
- Misoprostol
- Keywords
- misoprostol, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called cytotec
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
| Study group | Role | What they receive |
|---|---|---|
| hourly misoprostol | Experimental | 20 microgram misoprostol intake per hour Receives: Drug: Misoprostol |
| traditional misoprostol | Active comparator | 80 microgram misoprostol intake per 4 hours Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)
Measured: 480 min post start of oral misoprostol administration
Secondary outcomes (2)
AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes)
Measured: 240 min post start of oral misoprostol administration
AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes)
Measured: 360 min post start of oral misoprostol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypotonic; LaborStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Yann Cheng, China Medical University Hospital
- Investigators
- Shi-Yann Cheng, M.D., Principal investigator, China Medical University Beigang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271257
- Sponsor's protocol ID
- CMUBH R990011
- Other IDs
- DMR-IRB-242
- Status last verified
- Jan 2016
- First submitted
- 5 Jan 2011
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11821273Zieman 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.
PubMed 9207820
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Titrated Oral Misoprostol
- ClinicalTrials.gov ID
- NCT01271257
- Acronym / sponsor ID
- CMUBH R990011
- Conditions
- Hypotonic; Labor
- Keywords
- misoprostol, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hourly misoprostol | Experimental | Drug: Misoprostol20 microgram misoprostol intake per hour |
| traditional misoprostol | Active comparator | Drug: Misoprostol80 microgram misoprostol intake per 4 hours |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-40 Y/O healthy and non-pregnant woman
Key exclusion criteria (1 listed)
- heart, liver or kidney disease, anaphylaxis to misoprostol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: cytotec20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses | Drug | hourly misoprostol, traditional misoprostol |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Background: PubMed 11821273Tang 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.
- Background: PubMed 9207820Zieman 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.
- China Medical University Beigang HospitalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi-Yann Cheng, M.D. principal investigator
China Medical University Beigang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Misoprostol in people with Hypotonic; Labor, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271257, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.