Trial Outcomes & Findings for Cannabinoids for Pain Control During Medical Abortion (NCT NCT03604341)
NCT ID: NCT03604341
Last Updated: 2020-04-07
Results Overview
Women will text responds to surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain using an 11-point numeric rating scale (NRS 0-10) where 0=no pain and 10=worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
24 hours after misoprostol administration
Results posted on
2020-04-07
Participant Flow
2 participants failed to meet the inclusion criteria after enrollment and were not assigned to a treatment group.
Participant milestones
| Measure |
Gestational Age up to 10w0d - Dronabinol
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
|
Gestational Age up to 10w0d - Placebo
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Gestational Age up to 10w0d - Dronabinol
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
|
Gestational Age up to 10w0d - Placebo
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Cannabinoids for Pain Control During Medical Abortion
Baseline characteristics by cohort
| Measure |
Gestational Age up to 10w0d - Dronabinol
n=35 Participants
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
|
Gestational Age up to 10w0d - Placebo
n=35 Participants
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain
|
Total
n=70 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
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 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
|
28.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Non-Hispanic
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after misoprostol administrationWomen will text responds to surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain using an 11-point numeric rating scale (NRS 0-10) where 0=no pain and 10=worst possible pain.
Outcome measures
| Measure |
Gestational Age up to 10w0d - Dronabinol
n=33 Participants
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
|
Gestational Age up to 10w0d - Placebo
n=33 Participants
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain
|
|---|---|---|
|
Maximum Self-reported Pain Score on a Numeric Rating Scale
|
7 score on a scale
Interval 6.0 to 8.0
|
7 score on a scale
Interval 5.0 to 8.0
|
Adverse Events
Gestational Age up to 10w0d - Dronabinol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Gestational Age up to 10w0d - Placebo
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 |
Gestational Age up to 10w0d - Dronabinol
n=35 participants at risk
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
|
Gestational Age up to 10w0d - Placebo
n=35 participants at risk
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.7%
2/35 • Number of events 2 • from enrollment to 21 days after abortion procedure
|
0.00%
0/35 • from enrollment to 21 days after abortion procedure
|
Additional Information
OB/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 503-494-3666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place