Osteoarthritis, KneePhase 2NCT01319929

A Study of LY2828360 in Patients With Osteoarthritic Knee Pain

A Phase 2 study testing LY2828360 in people with Osteoarthritis, Knee, run by Eli Lilly and Company at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: LY2828360
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteDenmark
Study dates: Mar 2011to Sep 2011
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are male or female participants with osteoarthritis (OA), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Male participants: agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
Female participants: women not of child-bearing potential due to surgical sterilization (at least 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause
Body weight greater than 40 kilograms (kg) and less than 120 kilograms (kg) with a body mass index (BMI) between 19-35 kilograms per square meter (kg/m^2) inclusive
Participant with osteoarthritic knee based on disease diagnostic criteria as presented in the Inclusion Disease Criteria, below
Blood pressure and pulse rate in supine and standing positions, within normal reference ranges for the population and investigator clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator

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Have clinical laboratory test results within normal reference range for the population or investigator clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling
Have agreed to maintain the same activity level throughout the course of the study
Have a unilateral or bilateral osteoarthritis (OA) of the knee diagnosed according to the American College of Rheumatology (ACR) criteria. The clinical diagnosis of osteoarthritis (OA) will be confirmed by the American College of Rheumatology (ACR) clinical and radiographic criteria for classification of idiopathic osteoarthritis (OA) of the knee based upon the following criteria:
Knee pain for at least 14 days per month for the 3 months before screening
Osteophytes (with radiographic evidence)
At least 1 of the following 3 conditions: Age greater than 50, or Morning stiffness less than 30 minutes, or Crepitus
Have a Kellgren and Lawrence grade of I, II, III or IV
Have a mean score of at least 4 (moderate) and less than or equal to 8 (moderate-severe) on the 24-hour average pain score (0-10) (question 1) in the participant e-diary from screening to randomization for the knee joint during walking
Discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics/Non-Steroidal Anti-Inflammatory Drug [NSAID]) at least 2 weeks prior to randomization (participants are allowed limited use of analgesic medications)

Who cannot join

Are currently enrolled in, have completed or discontinued within the last 3 months from, a clinical trial involving an off-label investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2828360, related compounds or any components of the formulation
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participation in the study
Have a recent or current history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Have current or previous (within the past year) Axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol or eating disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision, criteria, as determined by the investigator and confirmed by the Mini-International Neuropsychiatric Interview
Are judged by the Principal Investigator to be clinically at suicidal risk based upon clinical interview

Show all 39Show fewer

Have intercurrent illness or clinically significant adverse events
Have increased risk of seizures as evidenced by a history of seizures, stroke, surgery to the cerebral cortex, or head trauma with loss of consciousness
Have an alanine aminotransaminase (ALT) greater than 2.5 times Upper Limit of Normal (ULN) at Screening, based on reference ranges of the local laboratory. Moderate or greater hepatic impairment
Have prior renal transplant, current renal dialysis or severe renal insufficiency, or serum creatinine laboratory value greater than 1.5 times Upper Limit of Normal, based on the reference ranges of the local laboratory
Have clinically significant abnormal neurological examination, especially any evidence of tremor or nystagmus
Have a history of or symptoms suggestive of sleep apnoea
Use of any known strong inducers or inhibitors of Cytochrome P450 within 30 days prior to enrolment.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have a positive alcohol breath test at Screening
Show evidence of human immunodeficiency virus infection and/or positive human HIV antibodies
Have an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start)
Are at a high risk of infection
Have an autoimmune disorder
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Are women with a positive pregnancy test or women who are lactating or child bearing
Use prescription and herbal medications that cannot safely be discontinued by end of screening
Have donated blood of more than 500 milliliters (mL) within the last 3 months
Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to refrain alcohol consumption for the duration of the study
Are persons who have previously received the investigational product in study, have completed or withdrawn from this study or any other study investigation LY2828360
Are taking any excluded medications (analgesic medications) and over-the- counter medications that cannot be discontinued at screening
Show evidence or have any prior history of significant active neurological or psychiatric disease including depression
Have secondary causes of arthritis of the knee including septic arthritis, inflammatory joint disease, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, and primary osteochondromatosis
Have had lower extremity surgery (including arthroscopy of the index knee) within 6 months prior to Screening or have surgery planned of the index knee at anytime
Have had significant prior injury to the index knee within 12 months prior to Screening
Use of lower extremity assistive devices other than a cane or knee brace (use of a 'shoe lift' is permitted). 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
Have a confounding painful condition that may interfere with assessment of the index joint, that is, knee
Have any other musculoskeletal or arthritic condition that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study
Have used corticosteroid prior to baseline
Have received hyaluronan injections into index knee within the previous 6 months prior to Treatment Phase day 3
Have initiated or have changed to an established physiotherapy program within 2 weeks prior to Treatment Phase day 3 or during the study period An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity
Has had a prior synovial fluid analysis showing a White Blood Cell (WBC) greater than or equal to 2000 cubic millimeters (mm^3) that is indicative of a diagnosis other than OA
Have started recently or changed dose regimen of any OA specific therapies (that is, nutraceutical products)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aalborg

Other trials in Denmark

About this study

Official title: A Proof of Concept Study of the Effects of LY2828360 in the Treatment of Patients With Osteoarthritic Knee Pain.

To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain

Conditions: Osteoarthritis, Knee
Being tested: LY2828360, Placebo
Keywords: Osteoarthritis, knee pain, osteoarthritic knee pain
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2828360Drug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT01319929
Study group	Role	What they receive
LY2828360 then Placebo	Experimental	80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments. Receives: Drug: LY2828360; Drug: Placebo
Placebo then LY2828360	Experimental	Placebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments. Receives: Drug: LY2828360; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS)
The weekly mean of the 24-Hour APS was calculated from participants' daily entries for 24-hour average pain rating on an 11-point scale with scores from 0 (no pain) to 10 (worst possible pain). Data were recorded twice a day at approximately the same time each day, preferably first thing in the morning and in the afternoon.
Measured: Baseline, 4 weeks

Secondary outcomes (13)

Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)
Measured: Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC)
AUC from time zero to 8 hours (AUC0-8h) is reported for this outcome measure.
Measured: Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores
The pain severity for night pain and worst pain was measured by an 11-point Likert scale, an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was used for assessment of night pain and worst pain each day, and evaluated as weekly means. Participants were asked to complete the severity pain for worst pain twice a day (in the morning and in the afternoon). The pain severity for night pain was filled out only once in the morning.
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Chronic Pain Sleep Inventory (CPSI)
The CPSI is a validated 5-item questionnaire in which the following factors were assessed: trouble falling asleep due to pain (CPSI1), the need for sleep medication (CPSI2), awakenings by pain during the night (CPSI3) awakenings by pain in the morning (CPSI4), and overall sleep quality (CSPI5). All CPSI items are scored using a 100-millimeter (mm) visual analog scale (VAS) (VAS; 0=never and 100=always for CPSI1 through CPSI4, and 0=very poor and 100=excellent for CPSI5).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-rated questionnaire that assesses the participant's sleep habits during the last month and consists of 19 questions that cover 7 components (sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, sleeping medication use, and daytime dysfunction). Each item has a range of 0 (no difficulty) to 3 (severe difficulty). The 7 component scores were added to yield a global score with a range of 0 (no difficulty) to 21 (severe difficulties in all areas).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I)
The BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. BPI-S consists of 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and pain right now. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The BPI-I average interference is the average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference scores range: 0 (does not interfere) to 10 (completely interferes).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Investigator Global Assessment of Changes (IGAC)
The IGAC is an investigator-reported subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to answer the following question: If you take into consideration all the various ways the knee pain influence the participant and his/her life, how do you then evaluate the participant's condition today (0=very good and 100=very bad).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Patient Global Assessment of Changes (PGAC)
The PGAC is a self-reported subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to answer the following question: If you take into consideration all the various ways the knee pain influence you and your life how do you then evaluate your condition over the last week (0=very good and 100=very bad).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Western Ontario and MacMaster (WOMAC)
WOMAC index completed by participant; consists of 24 questions, each based on 5-point Likert scale (0=none to 4=extreme). Has 3 subscales: pain, stiffness, and physical function. Pain subscale has 5 questions on pain associated with everyday tasks; subscale score ranges from 0=none to 20=extreme. Physical function subscale has 17 questions on physical function difficulties with everyday tasks; subscale score ranges from 0=none to 68=extreme. Stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in day); subscale score ranges from 0=none to 8=extreme.
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Pain From 40 Meter Self-Paced Walk Test
The 40 meter self-paced walk test is a participant-rated subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to assess pain after walking 40 meters. Scores range from 0 (no pain) to 100 (worst pain).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in the 11 Step Stair Climb Test
The 11 step stair climb test is a participant-rated subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to assess pain after climbing 11 stairs. Scores range from 0 (no pain) to 100 (worst pain).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in DoloTest Sum Score
The DoloTest® is a self-reported assessment composed of 8 visual analog scale (VAS) items ranging from 0 (none) to 100 (worst possible) for the following domains: pain, problems with light physical activities, problems with more strenuous physical activities, problems doing your job, reduced energy and strength, low spirit, reduced social life, and problems sleeping). The scale is arranged in a radar plot to provide a graphic presentation of the test result. The DoloTest® Sum Score is equal to the sum of each scored domain; scores range from 0 (none) to 800 (worst possible).
Measured: Baseline, 4 weeks
Number of Participants With Treatment-Emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Measured: Baseline up to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Sep 2011

First posted22 Mar 2011 (estimated)
Study startMar 2011
Primary completionSep 2011
Study completionSep 2011

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, KneeStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01319929
Sponsor's protocol ID: 14165
Other IDs: I4F-EW-CCAC
Status last verified: May 2020
First submitted: 18 Mar 2011
Last updated: 19 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept Study of the Effects of LY2828360 in the Treatment of Patients With Osteoarthritic Knee Pain.
ClinicalTrials.gov ID: NCT01319929
Acronym / sponsor ID: 14165
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, knee pain, osteoarthritic knee pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 22 Mar 2011 (estimated)
Results: Posted 19 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY2828360 then Placebo	Experimental	Drug: LY2828360, Drug: Placebo80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.
Placebo then LY2828360	Experimental	Drug: LY2828360, Drug: PlaceboPlacebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Are male or female participants with osteoarthritis (OA), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Body weight greater than 40 kilograms (kg) and less than 120 kilograms (kg) with a body mass index (BMI) between 19-35 kilograms per square meter (kg/m^2) inclusive
Participant with osteoarthritic knee based on disease diagnostic criteria as presented in the Inclusion Disease Criteria, below
Blood pressure and pulse rate in supine and standing positions, within normal reference ranges for the population and investigator clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have clinical laboratory test results within normal reference range for the population or investigator clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator

Key exclusion criteria (39 listed)

Are currently enrolled in, have completed or discontinued within the last 3 months from, a clinical trial involving an off-label investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2828360, related compounds or any components of the formulation
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participation in the study
Have a recent or current history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Have current or previous (within the past year) Axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol or eating disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision, criteria, as determined by the investigator and confirmed by the Mini-International Neuropsychiatric Interview

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
LY2828360Administered orally	Drug	LY2828360 then Placebo, Placebo then LY2828360
PlaceboAdministered orally	Drug	LY2828360 then Placebo, Placebo then LY2828360

Primary outcome

Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS)
Time frame: Baseline, 4 weeks
The weekly mean of the 24-Hour APS was calculated from participants' daily entries for 24-hour average pain rating on an 11-point scale with scores from 0 (no pain) to 10 (worst possible pain). Data were recorded twice a day at approximately the same time each day, preferably first thing in the morning and in the afternoon.

13 secondary outcomes

Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)
Time frame: Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC)
Time frame: Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Chronic Pain Sleep Inventory (CPSI)
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I)
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Investigator Global Assessment of Changes (IGAC)
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Patient Global Assessment of Changes (PGAC)
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Western Ontario and MacMaster (WOMAC)
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in Pain From 40 Meter Self-Paced Walk Test
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in the 11 Step Stair Climb Test
Time frame: Baseline, 4 weeks
Change From Baseline to 4 Week Endpoint in DoloTest Sum Score
Time frame: Baseline, 4 weeks
Number of Participants With Treatment-Emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to 15 weeks

Results and safety

Results posted to the registry on 19 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
80 mg LY2828360 First, Then Placebo	20	17
Placebo First, Then 80 mg LY2828360	19	17

Primary outcome: Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS)

Time frame: Baseline, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	80 mg LY2828360 n = 34	Placebo n = 34
Value	-0.90 (1.03)	-1.20 (1.50)

Population analysed: The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline and at least 1 post-baseline weekly mean 24-Hour Average Pain value.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
80 mg LY2828360	0 of 37 (0%)	14 of 37 (37.8%)	Not reported
Placebo	0 of 36 (0%)	16 of 36 (44.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2828360 in people with Osteoarthritis, Knee, run by Eli Lilly and Company at 1 site in Denmark.

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 16 inclusion and 39 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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. 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 19 May 2020). 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 to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS) (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01319929.

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 19 May 2020.