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Phase 2 N=39 Randomized Double-blind Other

A Study of LY2828360 in Patients With Osteoarthritic Knee Pain

Osteoarthritis, Knee

Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS) — -0.90; -1.20 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
LY2828360 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Sep 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS)
-0.90; -1.20
SECONDARY
Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)
464.4
SECONDARY
Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC)
2803.9
SECONDARY
Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores
-0.80; -1.15; -0.85; -1.25
SECONDARY
Change From Baseline to 4 Week Endpoint in Chronic Pain Sleep Inventory (CPSI)
-0.6; -0.6; 0.0; -0.1; -0.5; -0.8
SECONDARY
Change From Baseline to 4 Week Endpoint in Pittsburgh Sleep Quality Index (PSQI)
-0.9; -0.7
SECONDARY
Change From Baseline to 4 Week Endpoint in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I)
-1.0; -1.0; -0.6; -0.8; -0.9; -1.1
SECONDARY
Change From Baseline to 4 Week Endpoint in Investigator Global Assessment of Changes (IGAC)
-8.6; -8.6
SECONDARY
Change From Baseline to 4 Week Endpoint in Patient Global Assessment of Changes (PGAC)
-9.6; -10.5
SECONDARY
Change From Baseline to 4 Week Endpoint in Western Ontario and MacMaster (WOMAC)
-0.9; -1.6; -0.5; -0.5; -3.4; -3.9
SECONDARY
Change From Baseline to 4 Week Endpoint in Pain From 40 Meter Self-Paced Walk Test
-7.8; -8.4
SECONDARY
Change From Baseline to 4 Week Endpoint in the 11 Step Stair Climb Test
-4.0; -9.0
SECONDARY
Change From Baseline to 4 Week Endpoint in DoloTest Sum Score
-34.5; -51.5
SECONDARY
Number of Participants With Treatment-Emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
0; 0; 0; 0

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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

Inclusion Disease Criteria

  • 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)

Exclusion Criteria

  • 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 disor
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01319929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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