Trial Outcomes & Findings for Opioid Analgesia for MAB (NCT NCT03139240)
NCT ID: NCT03139240
Last Updated: 2019-08-28
Results Overview
Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
172 participants
Primary outcome timeframe
24 hours after misoprostol administration
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Oxycodone: <7 Weeks of Gestation
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks randomized to oxycodone 10mg oral
|
Placebo: <7 Weeks Gestational Age
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
Oxycodone: 7-10w0d Gestational Age
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo: 7-10w0d Gestational Age
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
38
|
38
|
|
Overall Study
COMPLETED
|
48
|
47
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Oxycodone: <7 Weeks of Gestation
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks randomized to oxycodone 10mg oral
|
Placebo: <7 Weeks Gestational Age
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
Oxycodone: 7-10w0d Gestational Age
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo: 7-10w0d Gestational Age
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Opioid Analgesia for MAB
Baseline characteristics by cohort
| Measure |
Oxycodone: <7 Weeks Gestational Age
n=48 Participants
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks randomized to oxycodone 10mg oral
|
Placebo: <7 Weeks Gestational Age
n=48 Participants
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks randomized to placebo
|
Oxycodone: 7-10w0d Weeks Gestational Age
n=38 Participants
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo: 7-10w0d Weeks Gestational Age
n=38 Participants
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age 7-10w0d randomized to placebo
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
38 Participants
n=157 Participants
|
172 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
38 Participants
n=157 Participants
|
172 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
White/Non-Hispanic
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
14 Participants
n=157 Participants
|
93 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
79 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
48 participants
n=107 Participants
|
38 participants
n=206 Participants
|
38 participants
n=157 Participants
|
172 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: 24 hours after misoprostol administrationWomen text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
Outcome measures
| Measure |
Oxycodone Arm
n=86 Participants
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo Arm
n=86 Participants
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
|---|---|---|
|
Overall Maximum Self-reported Pain Score
|
8 units on a scale
Interval 2.0 to 10.0
|
8 units on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: 24 hours after misoprostol administrationPopulation: Participants at \<7 weeks of Gestation were assessed. Participants who were "lost to follow-up" were excluded from this analysis.
Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
Outcome measures
| Measure |
Oxycodone Arm
n=48 Participants
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo Arm
n=47 Participants
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
|---|---|---|
|
<7 Weeks of Gestation - Maximum Self-reported Pain Score
|
8 units on a scale
Interval 2.0 to 10.0
|
8 units on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: 24 hours after misoprostol administrationPopulation: Participants at 7-10w0d of Gestation were assessed. Participants who were "lost to follow-up" were excluded from this analysis.
Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
Outcome measures
| Measure |
Oxycodone Arm
n=37 Participants
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo Arm
n=38 Participants
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
|---|---|---|
|
7-10 Weeks Gestation - Maximum Self-reported Pain Score
|
9 units on a scale
Interval 2.0 to 10.0
|
8 units on a scale
Interval 4.0 to 10.0
|
Adverse Events
Oxycodone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxycodone
n=86 participants at risk
Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral
|
Placebo
n=86 participants at risk
Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks and women with a gestational age 7-10w0d randomized to placebo
|
|---|---|---|
|
Reproductive system and breast disorders
Ongoing pregnancy
|
4.7%
4/86 • Number of events 4 • 21 days
|
2.3%
2/86 • Number of events 2 • 21 days
|
Additional Information
Ob/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 5034940757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place