A Study of LY2828360 in Patients With Osteoarthritic Knee Pain

NCT01319929 | Completed Phase 2 Results

• 2 other identifiers: 14165I4F-EW-CCAC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Osteoarthritis, knee pain, osteoarthritic knee pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks

Secondary Outcomes (13)

• Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)

  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)

  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

  Baseline, 4 weeks

• Change From Baseline to 4 Week Endpoint in Chronic Pain Sleep Inventory (CPSI)

  Baseline, 4 weeks

• Change From Baseline to 4 Week Endpoint in Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 4 weeks

Study Arms (2)

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.

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.

Drug: LY2828360; Drug: Placebo

Interventions

LY2828360 DRUG

Administered orally

LY2828360 then Placebo; Placebo then LY2828360

Placebo DRUG

Administered orally

LY2828360 then Placebo; Placebo then LY2828360

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

CB2 receptor agonist LY2828360

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Locations

DK (1)