Trial Outcomes & Findings for Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals (NCT NCT00218062)
NCT ID: NCT00218062
Last Updated: 2017-06-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
16 weeks
Results posted on
2017-06-21
Participant Flow
Participant milestones
| Measure |
D-Amphetamine 60mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
15
|
16
|
|
Overall Study
Received First Dose of Study Medication
|
16
|
11
|
10
|
12
|
|
Overall Study
COMPLETED
|
7
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Baseline characteristics by cohort
| Measure |
D-Amphetamine 60mg + Therapy
n=22 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=20 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=15 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=16 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
42.6 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
41.2 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
41.9 years
STANDARD_DEVIATION 9 • n=7 Participants
|
42 years
STANDARD_DEVIATION 8.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
62 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
20 participants
n=107 Participants
|
15 participants
n=206 Participants
|
16 participants
n=7 Participants
|
73 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All participants who received the first dose of study medication were included in this analysis.
Outcome measures
| Measure |
D-Amphetamine 60mg + Therapy
n=16 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=11 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=10 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=12 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
|
9.25 number of cocaine negative urines
Standard Deviation 13.45
|
6.09 number of cocaine negative urines
Standard Deviation 8.12
|
6 number of cocaine negative urines
Standard Deviation 7.73
|
4.91 number of cocaine negative urines
Standard Deviation 7.56
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
D-Amphetamine 60mg + Therapy
n=22 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=20 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=15 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=16 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
|
7 participants
|
4 participants
|
3 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
D-Amphetamine 60mg + Therapy
n=22 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=20 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=15 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=16 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Retention as Indicated by the Number of Participants Who Remained in the Study
|
7 participants
|
4 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
D-Amphetamine 60mg + Therapy
n=22 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=20 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=15 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=16 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
|
80.2 percentage of pills taken
|
34.5 percentage of pills taken
|
65.8 percentage of pills taken
|
73.2 percentage of pills taken
|
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
D-Amphetamine 60mg + Therapy
n=22 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=20 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=15 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=16 Participants
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
|
67.1 % of riboflavin-positive urine samples
|
70 % of riboflavin-positive urine samples
|
76.8 % of riboflavin-positive urine samples
|
66.7 % of riboflavin-positive urine samples
|
Adverse Events
D-Amphetamine 60mg + Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Modafinil 400mg + Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Modafinil 200mg + D-Amphetamine 30mg + Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo + Therapy
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 |
D-Amphetamine 60mg + Therapy
n=22 participants at risk
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 400mg + Therapy
n=20 participants at risk
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Modafinil 200mg + D-Amphetamine 30mg + Therapy
n=15 participants at risk
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
Placebo + Therapy
n=16 participants at risk
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
|
|---|---|---|---|---|
|
Cardiac disorders
Chest pain
|
4.5%
1/22 • Number of events 1 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
0.00%
0/16 • 16 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/22 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
0.00%
0/16 • 16 weeks
|
|
Vascular disorders
Migraine
|
0.00%
0/22 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
0.00%
0/16 • 16 weeks
|
|
Cardiac disorders
Change in electrocardiogram (EKG)
|
0.00%
0/22 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/16 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/16 • 16 weeks
|
Additional Information
Dr Joy M. Schmitz
The University of Texas Health Science Center at Houston
Phone: (713) 486-2867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place