Trial Outcomes & Findings for Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants (NCT NCT02205034)
NCT ID: NCT02205034
Last Updated: 2024-02-21
Results Overview
Occurrence of adverse event, description and quantification of their severity, imputability to repeated intranasal administration of OT (4IU every other day, 4 IU daily, 4IU twice daily) during the 7 days following the first administration.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
up to day 8 (Visit 8)
Results posted on
2024-02-21
Participant Flow
Participant milestones
| Measure |
First Arm
4IU of oxytocin every other day
oxytocin: Intranasal administration
|
Second Arm
4 IU of oxytocin daily
oxytocin: Intranasal administration
|
Third Arm
4 IU of oxytocin twice daily
oxytocin: Intranasal administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants
Baseline characteristics by cohort
| Measure |
First Arm
n=6 Participants
4IU of oxytocin every other day
oxytocin: Intranasal administration
|
Second Arm
n=6 Participants
4 IU of oxytocin daily
oxytocin: Intranasal administration
|
Third Arm
n=6 Participants
4 IU of oxytocin twice daily
oxytocin: Intranasal administration
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to day 8 (Visit 8)Occurrence of adverse event, description and quantification of their severity, imputability to repeated intranasal administration of OT (4IU every other day, 4 IU daily, 4IU twice daily) during the 7 days following the first administration.
Outcome measures
| Measure |
First Arm
n=6 Participants
4IU of oxytocin every other day
oxytocin: Intranasal administration
|
Second Arm
n=6 Participants
4 IU of oxytocin daily
oxytocin: Intranasal administration
|
Third Arm
n=6 Participants
4 IU of oxytocin twice daily
oxytocin: Intranasal administration
|
|---|---|---|---|
|
Occurence of Adverse Event
|
10 number of adverse events
|
9 number of adverse events
|
6 number of adverse events
|
SECONDARY outcome
Timeframe: Before and after 7 days of treatmentNOMAS score evaluate sucking/swallowing abilitites of infants during feeding; endpoint is the % of infants who reached a NOMAS score \<= 10 (normal score)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: before and after 7 days of treatmentVideofluoroscopy of swallowing score (VFSS score)
Outcome measures
Outcome data not reported
Adverse Events
First Arm
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Second Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Third Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
First Arm
n=6 participants at risk
4IU of oxytocin every other day
oxytocin: Intranasal administration
|
Second Arm
n=6 participants at risk
4 IU of oxytocin daily
oxytocin: Intranasal administration
|
Third Arm
n=6 participants at risk
4 IU of oxytocin twice daily
oxytocin: Intranasal administration
|
|---|---|---|---|
|
Infections and infestations
Pneumopathy
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
Other adverse events
| Measure |
First Arm
n=6 participants at risk
4IU of oxytocin every other day
oxytocin: Intranasal administration
|
Second Arm
n=6 participants at risk
4 IU of oxytocin daily
oxytocin: Intranasal administration
|
Third Arm
n=6 participants at risk
4 IU of oxytocin twice daily
oxytocin: Intranasal administration
|
|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
General disorders
Pyrexia
|
50.0%
3/6 • Number of events 3 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Gastrointestinal disorders
Teething
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Hepatobiliary disorders
Hepatocellular injury
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/6 • everyday during the trial so during 7 days
|
33.3%
2/6 • Number of events 3 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • everyday during the trial so during 7 days
|
33.3%
2/6 • Number of events 2 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • everyday during the trial so during 7 days
|
16.7%
1/6 • Number of events 2 • everyday during the trial so during 7 days
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • everyday during the trial so during 7 days
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
|
Investigations
Culture urine positive
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
33.3%
2/6 • Number of events 2 • everyday during the trial so during 7 days
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
33.3%
2/6 • Number of events 2 • everyday during the trial so during 7 days
|
|
Infections and infestations
Oral candidasis
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/6 • everyday during the trial so during 7 days
|
0.00%
0/6 • everyday during the trial so during 7 days
|
16.7%
1/6 • Number of events 1 • everyday during the trial so during 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place