Trial Outcomes & Findings for A Study in the Treatment of Osteoarthritis Knee Pain (NCT NCT00790790)
NCT ID: NCT00790790
Last Updated: 2012-04-17
Results Overview
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline, 5 weeks
Results posted on
2012-04-17
Participant Flow
Study Period 1 was an up to 5-week screening phase when participants stopped use of excluded medications (265 participants entered; 118 discontinued). Study Period 2 was a 5-week, double-blind therapy period when randomization and dispensing of study drug occurred. Study Period 3 was a 1-week washout phase when all study medication was stopped.
Participant milestones
| Measure |
Placebo
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Study Period 2: Therapy Phase
STARTED
|
49
|
50
|
48
|
|
Study Period 2: Therapy Phase
COMPLETED
|
37
|
32
|
27
|
|
Study Period 2: Therapy Phase
NOT COMPLETED
|
12
|
18
|
21
|
|
Study Period 3: 1-Week Washout Phase
STARTED
|
37
|
32
|
27
|
|
Study Period 3: 1-Week Washout Phase
COMPLETED
|
37
|
31
|
26
|
|
Study Period 3: 1-Week Washout Phase
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Study Period 2: Therapy Phase
Adverse Event
|
3
|
16
|
16
|
|
Study Period 2: Therapy Phase
Protocol Violation
|
1
|
1
|
0
|
|
Study Period 2: Therapy Phase
Withdrawal by Subject
|
7
|
0
|
2
|
|
Study Period 2: Therapy Phase
Lack of Efficacy
|
1
|
0
|
3
|
|
Study Period 2: Therapy Phase
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Study in the Treatment of Osteoarthritis Knee Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=50 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=48 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
59.59 years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
57.68 years
STANDARD_DEVIATION 7.88 • n=7 Participants
|
59.96 years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
59.06 years
STANDARD_DEVIATION 7.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
43 participants
n=5 Participants
|
124 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
31 participants
n=5 Participants
|
94 participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=32 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks
|
-2.05 units on a scale
Standard Error 0.29
|
-2.10 units on a scale
Standard Error 0.29
|
-2.09 units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=32 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks
|
-2.22 units on a scale
Standard Error 0.31
|
-2.13 units on a scale
Standard Error 0.32
|
-2.19 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=32 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks
|
-2.12 units on a scale
Standard Error 0.30
|
-2.37 units on a scale
Standard Error 0.31
|
-2.09 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of night pain and worst pain each day, evaluated as weekly means.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=48 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
|
17 participants
|
17 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks
|
-1.09 units on a scale
Standard Error 0.16
|
-1.04 units on a scale
Standard Error 0.17
|
-1.03 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
Average BPI-I was a self-reported scale measuring degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessed interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
|
-2.12 units on a scale
Standard Error 0.35
|
-2.07 units on a scale
Standard Error 0.36
|
-1.39 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, 5 WeeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
BPI-S was a self-reported scale measuring severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessed worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Worst Pain
|
-2.32 units on a scale
Standard Error 0.38
|
-2.78 units on a scale
Standard Error 0.40
|
-2.48 units on a scale
Standard Error 0.43
|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Least Pain
|
-1.59 units on a scale
Standard Error 0.34
|
-1.99 units on a scale
Standard Error 0.34
|
-1.84 units on a scale
Standard Error 0.36
|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Average Pain
|
-1.99 units on a scale
Standard Error 0.31
|
-2.30 units on a scale
Standard Error 0.32
|
-1.91 units on a scale
Standard Error 0.35
|
|
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S Current Pain
|
-2.18 units on a scale
Standard Error 0.36
|
-2.36 units on a scale
Standard Error 0.37
|
-2.09 units on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Week 5Population: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
PGI-I was a scale that measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks
|
2.89 units on a scale
Standard Error 0.23
|
2.73 units on a scale
Standard Error 0.24
|
2.96 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represented better sleep.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks
|
0.24 units on a scale
Standard Error 0.12
|
0.22 units on a scale
Standard Error 0.12
|
0.20 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
The Total WOMAC index (pain, stiffness, physical function subscales) was completed by the participant and had 24 questions. Each question was answered using a 5-point Likert scale (0 to 4). The Total score had a range from 0 (none) to 96 (extreme). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks
|
-18.03 units on a scale
Standard Error 2.83
|
-18.44 units on a scale
Standard Error 2.94
|
-19.92 units on a scale
Standard Error 3.15
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicated better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=44 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=41 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks
|
1.10 units on a scale
Standard Error 0.30
|
1.59 units on a scale
Standard Error 0.30
|
1.24 units on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=46 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=45 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score
|
0.11 units on a scale
Standard Error 0.03
|
0.07 units on a scale
Standard Error 0.03
|
0.05 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=47 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=44 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks
|
-3.36 units on a scale
Standard Error 1.08
|
-2.73 units on a scale
Standard Error 1.06
|
-2.86 units on a scale
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: The safety analysis population included all 147 participants randomized to study drug.
Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=50 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=48 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase
Therapy Phase
|
3 participants
|
16 participants
|
16 participants
|
|
Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase
1-Week Washout Phase
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The safety analysis population included all 147 participants randomized to study drug.
The number of participants by treatment group who had abnormal high or low laboratory values was summarized as serious adverse events (SAEs) from the "Investigations" system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=50 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=48 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Systolic Blood Pressure (mmHg)
|
-2.13 millimeters of mercury (mmHg)
Standard Error 1.81
|
-2.50 millimeters of mercury (mmHg)
Standard Error 1.87
|
-2.15 millimeters of mercury (mmHg)
Standard Error 2.03
|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Diastolic Blood Pressure (mmHg)
|
-2.00 millimeters of mercury (mmHg)
Standard Error 1.16
|
-0.49 millimeters of mercury (mmHg)
Standard Error 1.20
|
-0.39 millimeters of mercury (mmHg)
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Baseline, 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks
|
0.06 beats per minute (bpm)
Standard Error 1.13
|
0.59 beats per minute (bpm)
Standard Error 1.19
|
2.17 beats per minute (bpm)
Standard Error 1.32
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
The number of participants having QTcF and QTcB ECG change \>450 milliseconds (msec) was summarized.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=46 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=43 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
QTcB >450 msec
|
2 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
QTcF >450 msec
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 5Population: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, followup questions rated the degree to which the issue impaired his/her ability to do work or read.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=33 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=27 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
Yes
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
No
|
37 participants
|
32 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.
Clearance was the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=91 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)
|
90.5 Liter per hour (L/hr)
Interval 71.8 to 115.0
|
41.9 Liter per hour (L/hr)
Interval 37.4 to 47.6
|
—
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The safety analysis population included all 147 participants randomized to study drug.
The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the "Nervous system disorders" system organ class was summarized. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=50 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=48 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)
|
4 participants
|
14 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline through 5 weeksPopulation: The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.
Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 30% of the participants at risk had at least 30% response was reported.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=48 Participants
Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=47 Participants
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
|---|---|---|---|
|
Time to Response
|
28 Time (days)
|
16 Time (days)
|
24 Time (days)
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
LY545694 49 mg
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
LY545694 105 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo Washout
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY545694 49 mg Washout
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LY545694 105 mg Washout
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=50 participants at risk
Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=48 participants at risk
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
Placebo Washout
n=49 participants at risk
1 week washout period from taking placebo
|
LY545694 49 mg Washout
n=50 participants at risk
1 week washout period from taking 49 mg LY545694
|
LY545694 105 mg Washout
n=48 participants at risk
1 week washout period from taking 105 mg LY545694
|
|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
Blood glucose increased
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
|
Vascular disorders
Hypertension
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
|
LY545694 49 mg
n=50 participants at risk
Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
|
LY545694 105 mg
n=48 participants at risk
Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
|
Placebo Washout
n=49 participants at risk
1 week washout period from taking placebo
|
LY545694 49 mg Washout
n=50 participants at risk
1 week washout period from taking 49 mg LY545694
|
LY545694 105 mg Washout
n=48 participants at risk
1 week washout period from taking 105 mg LY545694
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Eye disorders
Presbyopia
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Eye disorders
Vision blurred
|
8.2%
4/49 • Number of events 4
|
2.0%
1/50 • Number of events 1
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
|
Eye disorders
Visual impairment
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/49
|
0.00%
0/50
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
3/49 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Constipation
|
6.1%
3/49 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Nausea
|
8.2%
4/49 • Number of events 4
|
20.0%
10/50 • Number of events 13
|
35.4%
17/48 • Number of events 23
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49 • Number of events 2
|
12.0%
6/50 • Number of events 8
|
22.9%
11/48 • Number of events 14
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
General disorders
Asthenia
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
10.4%
5/48 • Number of events 5
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
General disorders
Chills
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
General disorders
Fatigue
|
0.00%
0/49
|
6.0%
3/50 • Number of events 3
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
General disorders
Gait disturbance
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Irritability
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
General disorders
Pain
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Immune system disorders
Food allergy
|
2.0%
1/49 • Number of events 2
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/49
|
4.0%
2/50 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Infections and infestations
Onychomycosis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Infections and infestations
Sinusitis
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Blood calcium increased
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
Blood potassium decreased
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
Blood pressure increased
|
0.00%
0/49
|
6.0%
3/50 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
Neutrophil count increased
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
Weight increased
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Investigations
White blood cell count increased
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
2/49 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Amnesia
|
0.00%
0/49
|
0.00%
0/50
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/49
|
4.0%
2/50 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49
|
10.0%
5/50 • Number of events 5
|
12.5%
6/48 • Number of events 7
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Headache
|
6.1%
3/49 • Number of events 3
|
12.0%
6/50 • Number of events 8
|
14.6%
7/48 • Number of events 7
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/49 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Poor quality sleep
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Somnolence
|
0.00%
0/49
|
4.0%
2/50 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Nervous system disorders
Tremor
|
0.00%
0/49
|
4.0%
2/50 • Number of events 2
|
8.3%
4/48 • Number of events 4
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/49
|
4.0%
2/50 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Aggression
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
4.0%
2/50 • Number of events 2
|
0.00%
0/48
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Expressive language disorder
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Insomnia
|
8.2%
4/49 • Number of events 4
|
12.0%
6/50 • Number of events 6
|
8.3%
4/48 • Number of events 4
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/49
|
0.00%
0/50
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/49
|
2.0%
1/50 • Number of events 2
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Social circumstances
Verbal abuse
|
0.00%
0/49
|
0.00%
0/50
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
|
Vascular disorders
Hypertension
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/48
|
|
Vascular disorders
Varicose vein
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/50
|
0.00%
0/48
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60