AzTrials
AzTrials

Postpartum HemorrhagePhase 1NCT02999100

Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

A Phase 1 study testing IH Oxytocin, IM Oxytocin and IV Oxytocin in people with Postpartum Hemorrhage, run by GlaxoSmithKline at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study is being conducted to further assess safety and tolerability of inhaled oxytocin, and to characterize the drug levels of inhaled (IH)… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
IH Oxytocin, IM Oxytocin and IV Oxytocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
3 sitesin 2 countries
Study dates
23 Nov 2016to 4 Mar 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • All Groups:
  • Between 18 and 40 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, and laboratory tests as required per protocol.
  • Subject clinical chemistry and haematology values within an acceptable range for the population recruited and not of abnormal clinical significance. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor (if required) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Adequate peripheral venous access for cannulation.
  • Group 1 Only:
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  • Currently pregnant, with an uncomplicated pregnancy as determined by the investigator or designee.
  • Estimated date of delivery within 24 weeks of screening.
  • Planned spontaneous vaginal birth and considered by investigator at low risk for post partum hemorrhage (PPH).
  • Planned birth in between the 37th and 42nd week of pregnancy.
  • Women who qualify for oxytocin as appropriate for active management of TSL and who agree to have active management.
  • Group 2 Only:
  • ECG normal, or abnormal and not clinically significant.
  • FEV1 >80% of predicted.
  • Systolic blood pressure >=90 millimeters of mercury (mmHg).
  • Body mass index (BMI) within the range 18 - 32 Kilogram (kg)/square meter (m^2) (inclusive).
  • Sex-Female.
  • Group 2, Cohort A Only:
  • A female subject is eligible to participate if she is confirmed to be not pregnant at screening and on Day 1 (as confirmed by a negative serum or urine human chorionic gonadotrophin [hCG] test), not lactating, and the following condition applies:
  • Is of reproductive potential and agrees to use the same combined estrogen and progestogen oral contraceptive from 3 months prior to the first dose of study medication and until the follow-up contact.
  • This method of contraception is only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use their method of contraception
  • Group 2, Cohort B Only:
  • A female subject is eligible to participate if she is confirmed to be not pregnant at screening and on Day 1 (as confirmed by a negative serum or urine hCG test), not lactating, and one of the following conditions applies:
  • Is of reproductive potential and has been using the same non-hormonal contraceptive method from 3 months prior to the first dose of study medication and until the follow-up contact.
  • Would be of reproductive potential, but has undergone bilateral tubal ligation or occlusion or bilateral salpingectomy at least 12 months prior to first dose of study medication.
  • Is of reproductive potential with only same sex partners or who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis, when this is their preferred and usual lifestyle. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • These methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use their method(s) of contraception.
  • Of Note: Group 2, Cohort B will enrol women of reproductive potential if they agree to use a nonhormonal contraceptive method from at least one month prior to receiving study drug and until the follow-up assessment. Although condoms with spermicide are not considered a highly effective method of contraception, the risk of receiving study drug during pregnancy is minimal for the following reasons:
  • Pregnancy testing must be negative at screening and on the first day of dosing. Dosing is completed no greater than 14 days from the start of dosing. Oxytocin has a well established rapid half-life. If a patient happened to conceive during the time of dosing, study drug would be eliminated before implantation would occur.
  • All Groups: Capable of giving signed informed consent as described in Protocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Who cannot join

  • All Groups:
  • Postmenopausal as defined by gynaecological history.
  • Chronic lung condition of any etiology including asthma, Chronic obstructive pulmonary disease (COPD), emphysema, interstitial lung disease or active Tuberculosis (TB).
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Blood pressure >140 systolic or >90 diastolic.
  • Group 1 Only:
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  • Females with planned Caesarean Section.
  • Females with significant medical complications as determined by investigator.
  • Group 2 Only:
  • Currently breastfeeding or lactating.
  • QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).
  • Alanine aminotransferase (ALT) and bilirubin >1.5 Upper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Subjects with highly-active or symptomatic gynaecological disorders (such as large symptomatic fibroids).
  • All Groups:
  • Prescription or non-prescription drugs not approved by the investigator.
  • Oxytocin for any reason (including, but not limited to, induction or augmentation of labour) prior to administration of study-related oxytocin.
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 units. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 milliliter [ml]) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
  • Current smokers or subjects with a history of smoking within 6 months of screening, or with a total pack year history of >5 pack years. Confirmatory use via a Smokerlyzer is at the discretion of the local investigator, but is advised if the subject's recent smoking history is in doubt.
  • History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation (e.g. allergy to any previous inhaler use).
  • Participation in another clinical trial, which in the opinion of the investigator, jeopardizes the subject's safety or study outcomes.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
  • The subject has participated in a clinical trial and has received an investigation product within the following time period prior to the first dosing day in the current study: 30 days or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Group 2 Only:
  • Presence of hepatitis B surface antigen or positive hepatitis C antibody test result.
  • A positive Human Immunodeficiency Virus (HIV) antibody test.
  • A positive pre-study drugs of abuse test (not explained by diet or approved concomitant medications).
  • A positive alcohol breath test.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United Kingdom2 sites

  • GSK Investigational Site

    Cambridge, Cambridgeshire, CB2 2GG

  • GSK Investigational Site

    Cambridge, CB2 2GG

Other trials in United Kingdom

Australia1 site

  • GSK Investigational Site

    Clayton, Victoria, 3168

Other trials in Australia

About this study

Official title: A Randomized, Open-label Study to Characterize the Pharmacokinetics of Inhaled Oxytocin (GR121619) Compared With IM Oxytocin in Women in the Third Stage of Labour, and With IV Oxytocin in Non-pregnant, Non-lactating Women of Childbearing Potential

The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study is being conducted to further assess safety and tolerability of inhaled oxytocin, and to characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active management of the third stage of labour (after the baby is born). Group 2 will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the safety and tolerability of IH and IV oxytocin.

Being tested
IH Oxytocin, IM Oxytocin, IV Oxytocin, ROTAHALER
Keywords
oxytocin, non-pregnant, pregnant, Postpartum Hemorrhage
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IH OxytocinDrug

    Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).

  • IM OxytocinDrug

    Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration

  • IV OxytocinDrug

    Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.

  • ROTAHALERDevice

    ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin

Study groups in NCT02999100
Study groupRoleWhat they receive
Group 1 -IH oxytocinExperimentalWomen with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 400 micrograms (mcg) IH oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days
Receives: Drug: IH Oxytocin; Device: ROTAHALER
Group 1 -IM oxytocinExperimentalWomen with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 10 I.U. IM oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days
Receives: Drug: IM Oxytocin
Group 2 (IH and IV oxytocin)ExperimentalGroup 2 will enrol healthy, non-pregnant, non-lactating female subjects of childbearing potential, and each subject will participate in 2 dosing sessions. Group 2 will be divided into two cohorts: Cohort A will enrol women on a combined oral contraceptive, and Cohort B will enrol women who are not using a hormonal form of contraceptive. Group 2 subjects will randomized to receive IH oxytocin, and IV oxytocin in a cross fashion. Subjects will be followed up in-person once between 7 days to 21 days
Receives: Drug: IH Oxytocin; Drug: IV Oxytocin; Device: ROTAHALER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Plasma Concentration Time Profile of Oxytocin

    Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

  2. Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

    Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

  3. Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin

    Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: 10 minutes post dose Day 1

  4. Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin

    Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: 20 minutes post dose Day 1

  5. Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin

    Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: 30 minutes post dose Day 1

  6. Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

    Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

  7. Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin

    Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1

  8. Part 1: Terminal Phase Half-life (t1/2) of Oxytocin

    Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.

    Measured: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1

  9. Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.

    Measured: Up to 37 days

  10. Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

    Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

  11. Part 2: Change From Baseline in SBP and DBP

    SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

    Measured: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

  12. Part 2: Change From Baseline in Heart Rate

    Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

    Measured: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

  13. Part 2: Absolute Values of Heart Rate

    Heart rate was measured in semi-supine position after 5 minutes rest

    Measured: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

  14. Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval

    Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.

    Measured: Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose

  15. Part 2: Number of Participants With Abnormal Respiratory Events

    Number of participants with abnormal respiratory events has been presented

    Measured: Up to Day 37

  16. Part 2: Forced Expiratory Volume at 1 Minute (FEV1)

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.

    Measured: Pre dose and 1 hour post dose on Day1

  17. Part 2: Percent Oxygen in Blood

    Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries

    Measured: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose

  18. Part 2: Absolute Values of Respiration Rate

    Respiration rate was measured in semi-supine position after 5 minutes rest

    Measured: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose

  19. Part 2: Plasma Concentration Time Profile of Oxytocin.

    Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

  20. Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

    Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

  21. Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin

    Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: 10 minutes post dose

  22. Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin

    Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: 20 minutes post dose

  23. Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin

    Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: 30 minutes post dose

  24. Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

    Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

  25. Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin

    Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

  26. Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only

    Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

  27. Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only

    Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

  28. Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin

    Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Secondary outcomes (10)

  1. Part 1: Number of Participants With Non-SAEs and SAEs

    An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.

    Measured: Up to 15 days

  2. Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

    Measured: 30 minutes and 2 hours post dose

  3. Part 1: Absolute Values of Heart Rate

    Heart rate was measured in semi-supine position after 5 minutes rest

    Measured: 30 minutes and 2 hours post dose

  4. Part 1: Absolute Values of Respiration Rate

    Respiration rate was measured in semi-supine position after 5 minutes rest

    Measured: 30 minutes and 2 hours post dose

  5. Part 1: Absolute Values of Temperature

    Body temperature was measured in semi-supine position after 5 minutes rest

    Measured: 30 minutes and 2 hours post dose

  6. Part 1: Change From Baseline in SBP and DBP

    SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

    Measured: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

  7. Part 1: Change From Baseline in Heart Rate

    Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

    Measured: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

  8. Part 1: Change From Baseline in Respiration Rate

    Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

    Measured: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

  9. Part 1: Change From Baseline in Body Temperature

    Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

    Measured: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

  10. Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin

    Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

    Measured: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study start23 Nov 2016
  3. Primary completion1 Mar 2019
  4. Study completion4 Mar 2019

Why it stopped: Inability to reliably measure plasma oxytocin levels during third stage labour, regardless of administration method (intramuscular or inhaled).

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999100
Sponsor's protocol ID
205920
Other IDs
2016-002672-27, 2016
Status last verified
Mar 2020
First submitted
1 Nov 2016
Last updated
23 Mar 2020
Data monitoring committee
No

Publications

  • Oliver VL, Siederer S, Cahn A, Gajewska-Knapik K, Gibson RA, Goodall C, Kirkpatrick C, Murray J, Nguyen TH, Schneider I, Lambert P, McIntosh MP, Parry S. Exploring the role of ex vivo metabolism on blood and plasma measurements of oxytocin among women in the third stage of labour: A post hoc study. Br J Clin Pharmacol. 2023 Dec;89(12):3669-3680. doi: 10.1111/bcp.15865. Epub 2023 Aug 24.

    PubMed 37522415

  • Gajewska-Knapik K, Kumar S, Sutton-Cole A, Palmer KR, Cahn A, Gibson RA, Kirkpatrick C, Parry S, Schneider I, Siederer S, Stylianou A, Hacquoil K, Powell M, Ellis M, McIntosh MP, Lambert P. Pharmacokinetics and safety of inhaled oxytocin compared with intramuscular oxytocin in women in the third stage of labour: A randomized open-label study. Br J Clin Pharmacol. 2023 Dec;89(12):3681-3689. doi: 10.1111/bcp.15860. Epub 2023 Aug 31.

    PubMed 37485589

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IH Oxytocin, IM Oxytocin and IV Oxytocin in people with Postpartum Hemorrhage, run by GlaxoSmithKline at 3 sites in 2 countries.

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 30 inclusion and 28 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: stopped early, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Australia. 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?

Yes. Results are posted in the registry (first posted 5 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Plasma Concentration Time Profile of Oxytocin (time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1). The study lists 28 primary outcomes in all. 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 NCT02999100, 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 23 Mar 2020.

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