Trial Outcomes & Findings for Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (NCT NCT02545127)

NCT ID: NCT02545127

Last Updated: 2024-02-07

Results Overview

Measured by weight in grams converted to volume in milliliters (mL)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Daily days 1 to 14

Results posted on

2024-02-07

Participant Flow

The trial was performed in 12 investigational sites in the US between May 2021 and November 2022.

In total, 15 participants were screened. Of these, 11 were screening failures and 4 participants were randomized. All the randomized participants were exposed to the investigational medicinal product (IMP): 2 participants to Merotocin and 2 participants to Placebo.

Participant milestones

Participant milestones
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Overall Study STARTED	2	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31 Years STANDARD_DEVIATION 1.4 • n=5 Participants	31.5 Years STANDARD_DEVIATION 6.4 • n=7 Participants	31.3 Years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Body Mass Index (BMI)	27.5 kg/m^2 STANDARD_DEVIATION 2.2 • n=5 Participants	31.7 kg/m^2 STANDARD_DEVIATION 0.1 • n=7 Participants	29.6 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: Daily days 1 to 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Measured by weight in grams converted to volume in milliliters (mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization (Day 1) to Day 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Number of days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization (Day 1) to Day 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Number of days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 to 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Measured by weight in grams converted to volume in milliliters (mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 to 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Measured by weight in grams converted to volume in milliliters (mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 15 to 17

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Measured by weight in grams converted to volume in milliliters (mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 to 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Measured by weight in grams converted to volume in milliliters (mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 to 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Measured by weight in grams converted to volume in milliliters (mL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 3

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 10

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Day 1) to Day 14

Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Screening (0-144 hours of delivery) up to Day 18

Outcome measures

Outcome measures
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Frequency of Adverse Events (AEs) in Maternal Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Screening (0-144 hours of delivery) up to Day 18

Outcome measures

Outcome measures
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Intensity of AEs in Maternal Participants	0 Severe Adverse Events	2 Severe Adverse Events

SECONDARY outcome

Timeframe: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.

Outcome measures

Outcome measures
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Frequency of AEs in Infants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.

Outcome measures

Outcome measures
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Intensity of AEs in Infants Mild adverse events	0 Adverse Events	2 Adverse Events
Intensity of AEs in Infants Moderate adverse events	0 Adverse Events	10 Adverse Events
Intensity of AEs in Infants Severe adverse events	0 Adverse Events	3 Adverse Events

SECONDARY outcome

Timeframe: From screening up to Day 15

Outcome measures

Outcome measures
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Changes in Routine Safety Laboratory Parameters in Maternal Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening up to Day 15

Outcome measures

Outcome measures
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 Participants Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 Participants Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values	0 Participants	0 Participants

Adverse Events

Merotocin (a Selective Oxytocin-receptor Agonist)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 participants at risk Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 participants at risk Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Infections and infestations Infections NEC	0.00% 0/2 • Adverse Events (AEs) were recorded from the time of signing ICF through the Day 18/Follow-up visit	50.0% 1/2 • Number of events 1 • Adverse Events (AEs) were recorded from the time of signing ICF through the Day 18/Follow-up visit

Other adverse events

Other adverse events
Measure	Merotocin (a Selective Oxytocin-receptor Agonist) n=2 participants at risk Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	Placebo n=2 participants at risk Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Injury, poisoning and procedural complications Non-site specific injuries NEC	0.00% 0/2 • Adverse Events (AEs) were recorded from the time of signing ICF through the Day 18/Follow-up visit	50.0% 1/2 • Number of events 1 • Adverse Events (AEs) were recorded from the time of signing ICF through the Day 18/Follow-up visit

Additional Information

Global Clinical Compliance

Ferring Pharmaceuticals

Phone: +1 833-548-1402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Publication restrictions are in place

Restriction type: OTHER