Osteoarthritis Knee PainPhase 2NCT00790790
A Study in the Treatment of Osteoarthritis Knee Pain
A Phase 2 study testing LY545694 49 mg and LY545694 105 mg in people with Osteoarthritis Knee Pain, run by Eli Lilly and Company at 10 sites in 3 countries.
Trial summary
To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis Knee Pain
- What is being tested?
- LY545694 49 mg and LY545694 105 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Nov 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with Osteoarthritis (OA) of the knee based on: 1) Knee pain for at least 14 days per month for the last 3 months, 2) Osteophytes (bone spurs), 3) And at least 1 of the following: Over the age of 50, OR morning stiffness in knee for less than 30 minutes, OR crunching sensation as the knee bends back and forth (crepitus).
- Mean score of 4 or greater on the 24-hour average pain score from Visit 2 to Visit 3.
- Completion of electronic daily diaries with at least 70% complete between Visit 2 and Visit 3.
- Taken non-steroidal anti-inflammatory drugs (NSAIDs) less than 15 days over the past month AND not taken NSAIDs at least 1 week prior to Visit 3.
- Agree to maintain the same activity level throughout the study.
- Women who can become pregnant must test negative for pregnancy and agree to utilize medically acceptable/reliable birth control during the study and 1 month following the last dose of the study.
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- Competent and freely able to give an informed consent.
- Ability to understanding and intelligibly communicate with the investigator.
- Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Who cannot join
- Knee arthroscopy within past 3 months or any knee joint replacement.
- Surgery planned during the trial for the knee to be studied.
- Prior synovial fluid analysis showing a white blood cell of 2000 cubic millimeters (mm^3) that is indicative of a diagnosis other than OA
- Are non-ambulatory or require the use of crutches or a walker. Use of a cane in the hand opposite the index knee is acceptable.
- Body Mass Index over 40.
- Confounding painful condition that may interfere with assessment of the index knee. (Knee pain should be the predominant pain. Mild OA of the hands is allowed, for instance.)
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- Diagnosis of inflammatory arthritis (rheumatoid arthritis) or an autoimmune disorder (except inactive Hashimoto's thyroiditis).
- Received intra-articular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 3 months.
- Frequent falls that could result in hospitalization or could compromise response to treatment.
- Current or previous (within the past 1 year) Axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, anxiety disorder, alcohol or eating disorders.
- Serious or unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition that in the opinion of investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
- Alanine transaminase (ALT) > 2.0 times upper limit of normal at Visit 1, based on reference ranges of the central lab.
- Prior renal transplant, current renal dialysis, or serum creatinine laboratory value >1.5 times upper limit of normal based on the reference ranges of the central lab.
- Diagnosis or past history of glaucoma. Subjects with intraocular pressure >24 millimeters of mercury (mm Hg).
- Are taking any excluded medications that cannot be discontinued at Visit 1.
- History of substance abuse or dependence within the past year, excluding nicotine and caffeine. Have a positive urine drug screen for any substance of abuse or excluded medication.
- History of recurrent seizures other than febrile seizures.
- Are judged by the investigator to be at suicidal risk.
- History of frequent and/or severe allergic reactions with multiple medications.
- Pregnant or breast-feeding.
- Are unwilling/unable to comply with the use of a data collection devices.
- Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Investigator site personnel directly affiliated with this study, and/or their immediate families, or Lilly employees.
- History of severe delay in stomach emptying (gastroparesis).
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States5 sites
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
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
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
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
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
Romania4 sites
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
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
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
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
Puerto Rico1 site
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
About this study
Official title: A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Osteoarthritis Knee Pain
To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.
- Conditions
- Osteoarthritis Knee Pain
- Being tested
- Placebo, LY545694 49 mg, LY545694 105 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
LY545694 placebo BID po for 5 weeks
LY545694 49 mgDrug
LY545694 49 mg BID po for 5 weeks.
LY545694 105 mgDrug
LY545694 105 mg BID po for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. Receives: Drug: Placebo |
| 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. Receives: Drug: LY545694 49 mg |
| 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. Receives: Drug: LY545694 105 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5 weeks
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis Knee PainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790790
- Sponsor's protocol ID
- 11978
- Other IDs
- H8C-MC-LQBG(a)
- Status last verified
- Apr 2012
- First submitted
- 12 Nov 2008
- Last updated
- 17 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Osteoarthritis Knee Pain
- ClinicalTrials.gov ID
- NCT00790790
- Acronym / sponsor ID
- 11978
- Conditions
- Osteoarthritis Knee Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 5 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. |
| LY545694 49 mg | Experimental | Drug: LY545694 49 mgParticipants 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 | Drug: LY545694 105 mgParticipants 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Present with Osteoarthritis (OA) of the knee based on: 1) Knee pain for at least 14 days per month for the last 3 months, 2) Osteophytes (bone spurs), 3) And at least 1 of the following: Over the age of 50, OR morning stiffness in knee for less than 30 minutes, OR crunching sensation as the knee bends back and forth (crepitus).
- Mean score of 4 or greater on the 24-hour average pain score from Visit 2 to Visit 3.
- Completion of electronic daily diaries with at least 70% complete between Visit 2 and Visit 3.
- Taken non-steroidal anti-inflammatory drugs (NSAIDs) less than 15 days over the past month AND not taken NSAIDs at least 1 week prior to Visit 3.
- Agree to maintain the same activity level throughout the study.
Key exclusion criteria (24 listed)
- Knee arthroscopy within past 3 months or any knee joint replacement.
- Surgery planned during the trial for the knee to be studied.
- Prior synovial fluid analysis showing a white blood cell of 2000 cubic millimeters (mm^3) that is indicative of a diagnosis other than OA
- Are non-ambulatory or require the use of crutches or a walker. Use of a cane in the hand opposite the index knee is acceptable.
- Body Mass Index over 40.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboLY545694 placebo BID po for 5 weeks | Drug | Placebo |
| LY545694 49 mgLY545694 49 mg BID po for 5 weeks. | Drug | LY545694 49 mg |
| LY545694 105 mgLY545694 105 mg BID po for 5 weeks. | Drug | LY545694 105 mg |
Primary outcome
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks
Time frame: Baseline, 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.
21 secondary outcomes
Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks
Time frame: Baseline, 5 weeks
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks
Time frame: Baseline, 5 weeks
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
Time frame: Baseline through 5 weeks
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks
Time frame: Baseline, 5 weeks
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
Time frame: Baseline, 5 weeks
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
Time frame: Baseline, 5 Weeks
Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks
Time frame: Week 5
Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks
Time frame: Baseline, 5 weeks
Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks
Time frame: Baseline, 5 weeks
Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks
Time frame: 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
Time frame: Baseline, 5 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks
Time frame: Baseline, 5 weeks
Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase
Time frame: Baseline through 6 weeks
Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values
Time frame: Baseline through 5 weeks
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Time frame: Baseline, 5 weeks
Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks
Time frame: Baseline, 5 weeks
Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
Time frame: Baseline through 5 weeks
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
Time frame: Week 5
Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)
Time frame: Baseline through 5 weeks
Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)
Time frame: Baseline through 5 weeks
Time to Response
Time frame: Baseline through 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY545694 49 mg and LY545694 105 mg in people with Osteoarthritis Knee Pain, run by Eli Lilly and Company at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Romania, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks (time frame: Baseline, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2012.