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| ID | Type | Description | Link |
|---|---|---|---|
| H8C-MC-LQBG(a) | Other Identifier | Eli Lilly and Company |
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To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. |
|
| LY545694 49 mg | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | LY545694 placebo BID po for 5 weeks |
| |
| LY545694 49 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks | 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. | Baseline, 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Spring Valley | California | 91978 |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 2: Therapy Phase |
|
| |||||||||||||||||||||
| Study Period 3: 1-Week Washout Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block right | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| C000593718 | dasolampanel etibutil |
Not provided
Not provided
Not provided
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| Drug |
LY545694 49 mg BID po for 5 weeks. |
|
| LY545694 105 mg | Drug | LY545694 105 mg BID po for 5 weeks. |
|
| Baseline, 5 weeks |
| Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks | 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. | Baseline, 5 weeks |
| Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score | 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. | Baseline through 5 weeks |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks | 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. | Baseline, 5 weeks |
| Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks | 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. | Baseline, 5 weeks |
| Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks | 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. | Baseline, 5 Weeks |
| Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks | 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. | Week 5 |
| Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks | 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. | Baseline, 5 weeks |
| Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks | 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. | Baseline, 5 weeks |
| Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks | 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. | Baseline, 5 weeks |
| Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score | 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. | Baseline, 5 weeks |
| Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks | 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. | Baseline, 5 weeks |
| Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase | 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. | Baseline through 6 weeks |
| Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values | 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. | Baseline through 5 weeks |
| Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks | 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. | Baseline, 5 weeks |
| Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks | 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. | Baseline, 5 weeks |
| Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas | The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized. | Baseline through 5 weeks |
| Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks | 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. | Week 5 |
| Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm) | 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. | Baseline through 5 weeks |
| Number of Participants With Neurological Treatment Emergent Adverse Events (AEs) | 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. | Baseline through 5 weeks |
| Time to Response | 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. | Baseline through 5 weeks |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | DeLand | Florida | 32720 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | South Miami | Florida | 33143 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St Louis | Missouri | 63141 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Edison | New Jersey | 08817 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hato Rey | 00917 | Puerto Rico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasov | 500366 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | 70266 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Iași | 700656 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Târgu Mureş | 540136 | Romania |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| NOT COMPLETED |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| Secondary | Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score | 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. | 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. | Posted | Number | participants | Baseline through 5 weeks |
|
|
|
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 Weeks |
|
|
|
| Secondary | Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 5 |
|
|
|
| Secondary | Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 5 weeks |
|
|
|
| Secondary | Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase | 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. | The safety analysis population included all 147 participants randomized to study drug. | Posted | Number | participants | Baseline through 6 weeks |
|
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|
| Secondary | Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values | 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. | The safety analysis population included all 147 participants randomized to study drug. | Posted | Number | participants | Baseline through 5 weeks |
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| Secondary | Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 5 weeks |
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| Secondary | Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks | 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. | 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. | Posted | Least Squares Mean | Standard Error | beats per minute (bpm) | Baseline, 5 weeks |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas | The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized. | 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. | Posted | Number | participants | Baseline through 5 weeks |
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| Secondary | Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks | 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. | 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. | Posted | Number | participants | Week 5 |
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| Secondary | Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm) | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Liter per hour (L/hr) | Baseline through 5 weeks |
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| Secondary | Number of Participants With Neurological Treatment Emergent Adverse Events (AEs) | 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. | The safety analysis population included all 147 participants randomized to study drug. | Posted | Number | participants | Baseline through 5 weeks |
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| Secondary | Time to Response | 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. | 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. | Posted | Number | Time (days) | Baseline through 5 weeks |
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| 0 |
| 49 |
| 23 |
| 49 |
| EG001 | LY545694 49 mg | 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. | 1 | 50 | 34 | 50 |
| EG002 | 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. | 1 | 48 | 33 | 48 |
| EG003 | Placebo Washout | 1 week washout period from taking placebo | 0 | 49 | 1 | 49 |
| EG004 | LY545694 49 mg Washout | 1 week washout period from taking 49 mg LY545694 | 1 | 50 | 4 | 50 |
| EG005 | LY545694 105 mg Washout | 1 week washout period from taking 105 mg LY545694 | 0 | 48 | 2 | 48 |
| Snake bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| Motion sickness | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| Presbyopia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Lip blister | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Oesophageal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Blood calcium increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Nystagmus | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Psychomotor hyperactivity | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Speech disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Expressive language disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Micturition frequency decreased | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Verbal abuse | Social circumstances | MedDRA 12.0 | Systematic Assessment |
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| Dental implantation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| Limb operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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Not provided
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| BPI-S Average Pain |
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| BPI-S Current Pain |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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