Trial Outcomes & Findings for Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion (NCT NCT03480009)

Results Overview

Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

156 participants

Primary outcome timeframe

Over 24 hours starting from misoprostol administration

Results posted on

2020-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Dextromethorphan, Opted for Narcotic Prescription Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.	Placebo, Opted for Narcotic Prescription Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.	Dextromethorphan, Declined Narcotic Prescription Dextromethorphan hydrobromide and patient declines narcotic	Placebo, Declined Narcotic Prescription Avicel PH101 (Microcrystalline Cellulose NF) and patient declines narcotic
Overall Study STARTED	62	62	16	16
Overall Study COMPLETED	58	57	12	16
Overall Study NOT COMPLETED	4	5	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dextromethorphan, Opted for Narcotic Prescription Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.	Placebo, Opted for Narcotic Prescription Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.	Dextromethorphan, Declined Narcotic Prescription Dextromethorphan hydrobromide and patient declines narcotic	Placebo, Declined Narcotic Prescription Avicel PH101 (Microcrystalline Cellulose NF) and patient declines narcotic
Overall Study Lost to Follow-up	4	5	4	0

Baseline Characteristics

Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dextromethorphan, With Narcotic Prescription n=62 Participants Participants receiving dextromethorphan and a narcotic prescription	Placebo, With Narcotic Prescription n=62 Participants Participants receiving placebo and a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=16 Participants Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 Participants Participants receiving placebo and declined a narcotic prescription	Total n=156 Participants Total of all reporting groups
Age, Continuous	27.5 years STANDARD_DEVIATION 5.4 • n=5 Participants	25.8 years STANDARD_DEVIATION 4.4 • n=7 Participants	27.1 years STANDARD_DEVIATION 5.0 • n=5 Participants	26.1 years STANDARD_DEVIATION 5.3 • n=4 Participants	26.6 years STANDARD_DEVIATION 5.0 • n=21 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	62 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	156 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race : Non-Hispanic, Black	19 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	38 Participants n=21 Participants
Race/Ethnicity, Customized Race : Non-Hispanic, White	38 Participants n=5 Participants	38 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	97 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic, Black	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic, White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Prior medication abortion	12 Participants n=5 Participants	12 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	27 Participants n=21 Participants

PRIMARY outcome

Timeframe: Over 24 hours starting from misoprostol administration

Population: Intention to treat population where all participants were analyzed as randomized. Missing worst pain responses were imputed as 10 being the worst pain possible.

Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".

Outcome measures

Outcome measures
Measure	Dextromethorphan, Opted for Narcotic Prescription n=62 Participants Participants receiving dextromethorphan and opted for a narcotic prescription	Placebo, Opted for Narcotic Prescription n=62 Participants Participants receiving placebo and opted for a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=16 Participants Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 Participants Participants receiving placebo and declined a narcotic prescription
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)	8.0 score on a scale Interval 6.0 to 9.0	7.0 score on a scale Interval 5.0 to 9.0	7.5 score on a scale Interval 5.5 to 10.0	6.5 score on a scale Interval 4.0 to 8.0

PRIMARY outcome

Timeframe: Over 24 hours

Population: Missing data are for participants who did not take the specified pain medication

Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication.

Outcome measures

Outcome measures
Measure	Dextromethorphan, Opted for Narcotic Prescription n=62 Participants Participants receiving dextromethorphan and opted for a narcotic prescription	Placebo, Opted for Narcotic Prescription n=62 Participants Participants receiving placebo and opted for a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=16 Participants Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 Participants Participants receiving placebo and declined a narcotic prescription
Analgesic Usage During Medication Abortion ibuprofen	800 mg Interval 400.0 to 1200.0	600 mg Interval 400.0 to 1450.0	800 mg Interval 600.0 to 1600.0	1000 mg Interval 505.0 to 1400.0
Analgesic Usage During Medication Abortion 9acetaminophen	1000 mg Interval 825.0 to 2000.0	1300 mg Interval 1000.0 to 2500.0	800 mg Interval 600.0 to 1600.0	975 mg Interval 500.0 to 2000.0
Analgesic Usage During Medication Abortion oxycodone	10 mg Interval 10.0 to 20.0	15 mg Interval 10.0 to 20.0	—	15 mg Interval 15.0 to 15.0

SECONDARY outcome

Timeframe: Marginal mean pain scores over 24 hours

Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".

Outcome measures

Outcome measures
Measure	Dextromethorphan, Opted for Narcotic Prescription n=62 Participants Participants receiving dextromethorphan and opted for a narcotic prescription	Placebo, Opted for Narcotic Prescription n=62 Participants Participants receiving placebo and opted for a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=16 Participants Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 Participants Participants receiving placebo and declined a narcotic prescription
Mean Pain Scores Via Numeric Rating Scale (NRS-11)	2.93 score on a scale (NRS-11) Standard Deviation 2.92	2.96 score on a scale (NRS-11) Standard Deviation 2.76	2.70 score on a scale (NRS-11) Standard Deviation 2.95	2.41 score on a scale (NRS-11) Standard Deviation 2.88

SECONDARY outcome

Timeframe: 24 hours after misoprostol administration

Population: There are missing data for 3 participants in the dextromethorphan group (1 that opted for a narcotic prescription and 2 that declined) and 3 participants in the placebo (opted for narcotic prescription group).

Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"

Outcome measures

Outcome measures
Measure	Dextromethorphan, Opted for Narcotic Prescription n=61 Participants Participants receiving dextromethorphan and opted for a narcotic prescription	Placebo, Opted for Narcotic Prescription n=59 Participants Participants receiving placebo and opted for a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=14 Participants Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 Participants Participants receiving placebo and declined a narcotic prescription
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale Very poor	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale Poor	11 Participants	4 Participants	5 Participants	3 Participants
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale Good	27 Participants	30 Participants	7 Participants	8 Participants
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale Very good	20 Participants	25 Participants	2 Participants	5 Participants

Adverse Events

Dextromethorphan, Opted for Narcotic Prescription

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo, Opted for Narcotic Prescription

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Dextromethorphan, Declined Narcotic Prescription

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo, Declined Narcotic Prescription

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dextromethorphan, Opted for Narcotic Prescription n=62 participants at risk Participants receiving dextromethorphan and opted for a narcotic prescription	Placebo, Opted for Narcotic Prescription n=62 participants at risk Participants receiving placebo and opted for a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=16 participants at risk Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 participants at risk Participants receiving placebo and declined a narcotic prescription
Reproductive system and breast disorders Uterine hemorrhage	1.6% 1/62 • Number of events 1 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	0.00% 0/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	0.00% 0/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	0.00% 0/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later

Other adverse events

Other adverse events
Measure	Dextromethorphan, Opted for Narcotic Prescription n=62 participants at risk Participants receiving dextromethorphan and opted for a narcotic prescription	Placebo, Opted for Narcotic Prescription n=62 participants at risk Participants receiving placebo and opted for a narcotic prescription	Dextromethorphan, Declined Narcotic Prescription n=16 participants at risk Participants receiving dextromethorphan and declined a narcotic prescription	Placebo, Declined Narcotic Prescription n=16 participants at risk Participants receiving placebo and declined a narcotic prescription
General disorders Chills	16.1% 10/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	16.1% 10/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	31.2% 5/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	31.2% 5/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
Nervous system disorders Dizziness	14.5% 9/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	11.3% 7/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	12.5% 2/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	6.2% 1/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
Nervous system disorders Drowsiness	19.4% 12/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	21.0% 13/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	18.8% 3/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	25.0% 4/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
Gastrointestinal disorders Nausea	45.2% 28/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	37.1% 23/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	62.5% 10/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	50.0% 8/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
Gastrointestinal disorders Vomiting	22.6% 14/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	22.6% 14/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	37.5% 6/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	18.8% 3/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
Gastrointestinal disorders Diarrhea	12.9% 8/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	21.0% 13/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	43.8% 7/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	25.0% 4/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
Nervous system disorders Headache	9.7% 6/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	4.8% 3/62 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	6.2% 1/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later	25.0% 4/16 • 3-5 days after enrollment Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later

Additional Information

Principal Investigator, MD MPH

University of Pittsburgh

Phone: 412-641-5496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place