Trial Outcomes & Findings for Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia (NCT NCT01058642)
NCT ID: NCT01058642
Last Updated: 2015-07-30
Results Overview
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline, Week 2 of Treatment Period 1 or 2
Results posted on
2015-07-30
Participant Flow
Participant milestones
| Measure |
Treatment Sequence 3: Placebo Then ADL5747
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week
|
Treatment Sequence 4: ADL5747 Then Placebo
During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week.
|
Treatment Sequence 1: Placebo Then Pregabalin
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days.
|
Treatment Sequence 2: Pregabalin Then Placebo
Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).
At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
11
|
9
|
9
|
12
|
|
Treatment Period 1
Received at Least 1 Dose of Study Drug
|
11
|
9
|
9
|
12
|
|
Treatment Period 1
COMPLETED
|
9
|
7
|
7
|
11
|
|
Treatment Period 1
NOT COMPLETED
|
2
|
2
|
2
|
1
|
|
Washout Period
STARTED
|
9
|
7
|
7
|
11
|
|
Washout Period
COMPLETED
|
9
|
7
|
7
|
11
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
9
|
7
|
7
|
11
|
|
Treatment Period 2
Received at Least 1 Dose of Study Drug
|
9
|
7
|
7
|
11
|
|
Treatment Period 2
COMPLETED
|
9
|
7
|
7
|
11
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 3: Placebo Then ADL5747
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week
|
Treatment Sequence 4: ADL5747 Then Placebo
During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week.
|
Treatment Sequence 1: Placebo Then Pregabalin
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.
A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.
Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days.
|
Treatment Sequence 2: Pregabalin Then Placebo
Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).
At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.
Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.
At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week.
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
0
|
0
|
1
|
|
Treatment Period 1
Physician Decision
|
1
|
0
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Lack of Compliance with Study Drug
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: Placebo Then Pregabalin
n=9 Participants
Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
|
Treatment Sequence 2: Pregabalin Then Placebo
n=12 Participants
Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
|
Treatment Sequence 3: Placebo Then ADL5747
n=11 Participants
Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
|
Treatment Sequence 4: ADL5747 Then Placebo
n=9 Participants
ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.
Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 16.01 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 8.03 • n=4 Participants
|
62.5 years
STANDARD_DEVIATION 11.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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 (NIH/OMB)
Asian
|
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 (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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 (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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 (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
41 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2 of Treatment Period 1 or 2Population: Zero participants were analyzed, and no data was collected for this measure. Due to lack of efficacy of ADL5747, the study was terminated early.
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.
Outcome measures
Outcome data not reported
Adverse Events
ADL5747
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pregabalin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADL5747
n=18 participants at risk
ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
|
Placebo
n=38 participants at risk
Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
|
Pregabalin
n=19 participants at risk
Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
2/38 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
26.3%
5/19 • Number of events 5
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
10.5%
2/19 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Nervous system disorders
Gait Disturbance
|
5.6%
1/18 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
2/38 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
3/18 • Number of events 3
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Psychiatric disorders
Somnolence
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
15.8%
3/19 • Number of events 3
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
10.5%
2/19 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Nervous system disorders
Headache
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
2/38 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Psychiatric disorders
Dysarthria
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Cardiac disorders
Edema peripheral
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
General disorders
Feeling jittery
|
5.6%
1/18 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
General disorders
Hypoesthesia
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
General disorders
Hypoesthesia oral
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.6%
1/18 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Eye disorders
Nystagmus
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
General disorders
Paresthesia
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
2/38 • Number of events 2
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Renal and urinary disorders
Urine analysis abnormal
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/38
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
5.3%
1/19 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
|
Metabolism and nutrition disorders
Weight decreased
|
0.00%
0/18
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
2.6%
1/38 • Number of events 1
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
0.00%
0/19
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Phone: (781) 860-8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER