Trial Outcomes & Findings for Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy (NCT NCT05098067)
NCT ID: NCT05098067
Last Updated: 2024-02-07
Results Overview
Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
180 minutes
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
Intervention Group
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Capsaicin Topical Cream: 5g 0.075% applied once
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
Placebo Group
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=15 Participants
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Capsaicin Topical Cream: 5g 0.075% applied once
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
Placebo Group
n=15 Participants
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 years
n=15 Participants
|
28 years
n=15 Participants
|
26.5 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Parity
|
1 deliveries
n=15 Participants
|
1 deliveries
n=15 Participants
|
1 deliveries
n=30 Participants
|
|
BMI
|
23.5 kg/m^2
n=15 Participants
|
22.9 kg/m^2
n=15 Participants
|
23.4 kg/m^2
n=30 Participants
|
|
Gestational age
|
68 days
n=15 Participants
|
52 days
n=15 Participants
|
59.5 days
n=30 Participants
|
PRIMARY outcome
Timeframe: 180 minutesTime to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Capsaicin Topical Cream: 5g 0.075% applied once
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
Placebo Group
n=15 Participants
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
|---|---|---|
|
Time to Symptom Control
|
72 minutes
Interval 56.0 to 86.0
|
87 minutes
Interval 69.0 to 111.0
|
SECONDARY outcome
Timeframe: 180 minutesOutcome measures
| Measure |
Intervention Group
n=15 Participants
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Capsaicin Topical Cream: 5g 0.075% applied once
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
Placebo Group
n=15 Participants
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
|---|---|---|
|
Number of Antiemetics Needed for Symptom Control
1 additional antiemetic
|
2 Participants
|
4 Participants
|
|
Number of Antiemetics Needed for Symptom Control
2 additional antiemetics
|
1 Participants
|
1 Participants
|
|
Number of Antiemetics Needed for Symptom Control
3 additional antiemetics
|
1 Participants
|
0 Participants
|
|
Number of Antiemetics Needed for Symptom Control
4 additional antiemetics
|
0 Participants
|
0 Participants
|
|
Number of Antiemetics Needed for Symptom Control
0 additional antiemetics
|
11 Participants
|
10 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=15 participants at risk
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Capsaicin Topical Cream: 5g 0.075% applied once
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
Placebo Group
n=15 participants at risk
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Metoclopramide: 10mg IV once
Ondansetron: 8mg IV once if needed
Lactated Ringers, Intravenous: 1000cc once
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
66.7%
10/15 • Number of events 10 • Data collected over length of emergency room visit an average of 1.5 hours per participant
Patients self reported side effects
|
0.00%
0/15 • Data collected over length of emergency room visit an average of 1.5 hours per participant
Patients self reported side effects
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place