Trial Outcomes & Findings for RCT Comparing Methadone and Buprenorphine in Pregnant Women (NCT NCT00271219)
NCT ID: NCT00271219
Last Updated: 2015-08-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
birth
Results posted on
2015-08-05
Participant Flow
1074 Patients were screened for eligibility. 175 underwent randomization. 86 were assigned to receive buprenorphine. 58 of the patients assigned to buprenorphine completed the study. 89 were assigned to receive methadone. 73 of the patients assigned to methadone completed the study.
Of the 1074 screened: 243 did not give consent. 656 were excluded for a variety of reasons ranging from an estimated gestation age outside the range, to impending legal issues, to multiple-fetus pregnancy.
Participant milestones
| Measure |
Methadone
Methadone
Methadone : daily oral dosing 20-140 mg
|
Buprenorphine
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
86
|
|
Overall Study
COMPLETED
|
73
|
58
|
|
Overall Study
NOT COMPLETED
|
16
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RCT Comparing Methadone and Buprenorphine in Pregnant Women
Baseline characteristics by cohort
| Measure |
Methadone
n=73 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
Buprenorphine
n=58 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
Total
n=131 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
|
73 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
131 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
|
27.7 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
25.3 years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
40 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: birthOutcome measures
| Measure |
A Methadone
n=73 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=58 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Child's Head Circumference Measurement (Measured at Birth)
|
33.0 cm
Interval 32.7 to 33.3
|
33.8 cm
Interval 33.5 to 34.1
|
PRIMARY outcome
Timeframe: delivery until hospital discharge (min=2 days, max=79 days)Outcome measures
| Measure |
A Methadone
n=73 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=58 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Child's Length of Hospital Stay
|
17.5 days
Interval 16.0 to 19.0
|
10.0 days
Interval 8.8 to 11.2
|
PRIMARY outcome
Timeframe: From birth until hospital discharge (min=4 days, max=10, depending on site)Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.
Outcome measures
| Measure |
A Methadone
n=73 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=58 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)
|
41 participants
|
27 participants
|
PRIMARY outcome
Timeframe: minimum twice daily from birth until NAS no longer measured (min=10 days)NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.
Outcome measures
| Measure |
A Methadone
n=73 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=58 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Child's Peak Daily Total NAS Score
|
12.8 Score on the scale
Interval 12.2 to 13.4
|
11.0 Score on the scale
Interval 10.4 to 11.6
|
PRIMARY outcome
Timeframe: Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)Total amount in mg
Outcome measures
| Measure |
A Methadone
n=73 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=58 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS
|
10.4 mg
Interval 7.8 to 13.0
|
1.1 mg
Interval 0.4 to 1.8
|
SECONDARY outcome
Timeframe: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)Population: frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy
Outcome measures
| Measure |
A Methadone
n=89 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=86 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)
|
NA percentage of drug use
frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy
|
NA percentage of drug use
frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy
|
SECONDARY outcome
Timeframe: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)Population: frequency of occurrence too low to be estimated with accuracy
Outcome measures
| Measure |
A Methadone
n=89 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=86 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)
|
NA percentage of HIV risk behaviors
frequency of occurrence too low to be estimated with accuracy
|
NA percentage of HIV risk behaviors
frequency of occurrence too low to be estimated with accuracy
|
SECONDARY outcome
Timeframe: from study entry until discontinuation or delivery (min=29 days, max=239 days)Population: intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy
Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.
Outcome measures
| Measure |
A Methadone
n=89 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=86 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)
|
NA dose increase per trimester
intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy
|
NA dose increase per trimester
intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy
|
SECONDARY outcome
Timeframe: at deliveryThe Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.
Outcome measures
| Measure |
A Methadone
n=89 Participants
Methadone
Methadone : daily oral dosing 20-140 mg
|
B Buprenorphine
n=86 Participants
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
|---|---|---|
|
Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score
|
.014 Score on the scale
Interval -0.134 to 0.166
|
.088 Score on the scale
Interval -0.027 to 0.203
|
Adverse Events
Methadone: Mothers
Serious events: 14 serious events
Other events: 83 other events
Deaths: 0 deaths
Buprenorphine: Mothers
Serious events: 8 serious events
Other events: 66 other events
Deaths: 0 deaths
Methadone: Neonates
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Buprenorphine: Neonates
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methadone: Mothers
n=89 participants at risk
Methadone
Methadone : daily oral dosing 20-140 mg
|
Buprenorphine: Mothers
n=86 participants at risk
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
Methadone: Neonates
n=73 participants at risk
Neonates born to mothers maintained on methadone
|
Buprenorphine: Neonates
n=58 participants at risk
Neonates born to mothers maintained on buprenorphine
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abnormal fetal health
|
3.4%
3/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Cardiac disorders
cardiovascular
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
2.7%
2/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Gastrointestinal disorders
gastrointestinal
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Renal and urinary disorders
genitourinary
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Psychiatric disorders
Illicit drug use
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Nervous system disorders
neurological
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Pregnancy, puerperium and perinatal conditions
obstetrical
|
6.7%
6/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
2.3%
2/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Surgical and medical procedures
postsurgical
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Psychiatric disorders
psychological
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Social circumstances
psychosocial
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
2.7%
2/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Infections and infestations
sexually transmitted diseases
|
1.1%
1/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Skin and subcutaneous tissue disorders
skin conditions
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Nervous system disorders
sleep disturbances
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
General disorders
other
|
0.00%
0/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
Other adverse events
| Measure |
Methadone: Mothers
n=89 participants at risk
Methadone
Methadone : daily oral dosing 20-140 mg
|
Buprenorphine: Mothers
n=86 participants at risk
Buprenorphine
Buprenorphine : sl daily 2-32 mg
|
Methadone: Neonates
n=73 participants at risk
Neonates born to mothers maintained on methadone
|
Buprenorphine: Neonates
n=58 participants at risk
Neonates born to mothers maintained on buprenorphine
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abnormal fetal health
|
6.7%
6/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
4.7%
4/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Gastrointestinal disorders
abnormal appetite
|
2.2%
2/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
5.5%
4/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
General disorders
abnormal laboratory values
|
11.2%
10/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
9.3%
8/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Blood and lymphatic system disorders
blood-borne disorders
|
5.6%
5/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.2%
1/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Cardiac disorders
cardiovascular
|
32.6%
29/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
16.3%
14/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
11.0%
8/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
6.9%
4/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Endocrine disorders
endocrinologic
|
5.6%
5/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
3.5%
3/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Ear and labyrinth disorders
eye, ear, nose, or throat problems
|
13.5%
12/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
17.4%
15/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
General disorders
fever
|
3.4%
3/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
2.3%
2/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Gastrointestinal disorders
gastrointestinal
|
67.4%
60/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
54.7%
47/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
6.8%
5/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
6.9%
4/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Renal and urinary disorders
genitourinary
|
25.8%
23/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
18.6%
16/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Blood and lymphatic system disorders
hematopoietic or lymphatic symptoms
|
15.7%
14/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
17.4%
15/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
23.3%
17/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
24.1%
14/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Psychiatric disorders
Illicit drug use
|
11.2%
10/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
9.3%
8/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
4.1%
3/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
8.6%
5/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
General disorders
dental problems
|
24.7%
22/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
17.4%
15/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
3.4%
2/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
42.7%
38/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
32.6%
28/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
4.1%
3/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Nervous system disorders
neuromuscular
|
37.1%
33/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
33.7%
29/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Nervous system disorders
neurological
|
18.0%
16/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
14.0%
12/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Pregnancy, puerperium and perinatal conditions
obstetrical
|
32.6%
29/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
26.7%
23/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
4.1%
3/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
6.9%
4/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Surgical and medical procedures
postsurgical
|
18.0%
16/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
9.3%
8/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
4.1%
3/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
0.00%
0/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Psychiatric disorders
psychological
|
27.0%
24/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
24.4%
21/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Social circumstances
psychosocial
|
4.5%
4/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
5.8%
5/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
32.6%
29/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
36.0%
31/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
19.2%
14/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
20.7%
12/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Infections and infestations
sexually transmitted diseases
|
9.0%
8/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
9.3%
8/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.4%
1/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
1.7%
1/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Skin and subcutaneous tissue disorders
skin conditions
|
18.0%
16/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
14.0%
12/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
9.6%
7/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
3.4%
2/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Nervous system disorders
sleep disturbances
|
27.0%
24/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
23.3%
20/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
Nervous system disorders
somatic
|
21.3%
19/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
10.5%
9/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
—
0/0 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
|
General disorders
other AE
|
4.5%
4/89 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
3.5%
3/86 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
2.7%
2/73 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
5.2%
3/58 • Entire course of the study, from baseline to end of study period (min=26 days, max=239 days)
weekly assessment by self-report and clinician review with patient
|
Additional Information
Dr. Hendree Jones
Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, Johns Hopkins University School of Medicine
Phone: 919-485-2664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place