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Trial record 92 of 727 for:    Area Under Curve AND Bioavailability

Comparative Bioavailability Study of Two Misoprostol Formulations

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ClinicalTrials.gov Identifier: NCT02516631
Recruitment Status : Completed
First Posted : August 6, 2015
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Region Skane

Brief Summary:
The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.

Condition or disease Intervention/treatment Phase
Labour, Induced Drug: Angusta™ Drug: Cytotec® Phase 1

Detailed Description:

Prostaglandin E2 (dinoprostone) given vaginally or intra-cervically, and oxytocin have been the most commonly used preparations for induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. Misoprostol has anti-secretory and mucosal protective properties and was originally developed in the 1970s for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers. It is now used much more widely for 'off-label' indications like medication abortion, medical management of miscarriage, cervical ripening before surgical procedures, treatment of postpartum hemorrhage, and induction of labour. The lack of a specific license for Cytotec® to be used in obstetrics and gynecology has led to a number of problems regarding correct dose and dose regime.

The study is an open-label, randomized, single-dose, comparative, parallel design, bioavailability study followed by repeat dosing of of two formulations misoprostol in healthy adult females being induced to go into labour.

The drug shall be administered orally or sublingually.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following Single Oral or Sublingual Administration and Comparison of Safety of the Two Formulations Following Repeat Dosing Until Labour
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Oral (A)
One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg).
Drug: Angusta™
One tablet of Angusta™ (25 µg) given every 2 hours

Drug: Cytotec®
1/8 of a tablet of Cytotec® (25 µg) given every 2 hours. Drug administration should be repeated every 2 hours until labour has commenced.

Active Comparator: Oral (B)
Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®.
Drug: Angusta™
Two tablets of Angusta™ 25 µg given every 4 hours

Drug: Cytotec®
¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.

Active Comparator: Sublingual (C)
Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg.
Drug: Angusta™
Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours

Drug: Cytotec®
¼ of a tablet of Cytotec® (50 µg), given every 4 hours. Subjects should not swallow for a period of 5 minutes. Drug administration should be repeated every 4 hours until labour has commenced.




Primary Outcome Measures :
  1. AUC (area under the curve) 0-t misoprostol [ Time Frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose ]
  2. AUC (area under the curve) 0-inf of misoprostol [ Time Frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose ]

Secondary Outcome Measures :
  1. t max (Time to maximum) of misoprostol [ Time Frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose ]
  2. t 1/2 (Elimination half-life) of misoprostol [ Time Frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose ]
  3. APGAR score of infant [ Time Frame: At time of birth ]
  4. Cardiotochographic (CTG) monitoring. [ Time Frame: During labour ]
  5. Adverse event / Serious Adverse event profile. [ Time Frame: From screening and until 7 days post treatment. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult females
  • Women wanting to participate and having given informed consent
  • Known to have reached week 37 + 0 days to week 42 + 2 days of gestation
  • With a viable fetus in a vertex position
  • Age above or equal to 18 years old
  • Women opting for vaginal delivery
  • BMI between 20 and 30 kg/m2

Exclusion Criteria:

  • Women with known allergy to misoprostol or other prostaglandins
  • Women with prior caesarean section
  • Women with dead or anomalous fetus
  • Women with twin pregnancy
  • Women with known liver or renal dysfunction

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): NCT02516631


Locations
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Sweden
Skåne University Hospital Lund
Lund, Sweden
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Dag Wide-Swensson Region Skåne

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02516631     History of Changes
Other Study ID Numbers: AZ-201
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Keywords provided by Region Skane:
Labour, induced
Misoprostol
Pharmacokinetics
Cardiotocography
Safety
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics