Brief Summary

To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

147

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach

3 countries

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

November 1, 2008

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2011

Completed

Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

November 12, 2008

Results QC Date

August 25, 2011

Last Update Submit

April 11, 2012

Conditions

Osteoarthritis Knee Pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (21)

Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks
Baseline, 5 weeks
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks
Baseline, 5 weeks
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
Baseline through 5 weeks
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks
Baseline, 5 weeks
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
Baseline, 5 weeks
+16 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.

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.

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.

Drug: LY545694 105 mg

Interventions

PlaceboDRUG

LY545694 placebo BID po for 5 weeks

Placebo

LY545694 49 mgDRUG

LY545694 49 mg BID po for 5 weeks.

LY545694 49 mg

LY545694 105 mgDRUG

LY545694 105 mg BID po for 5 weeks.

LY545694 105 mg

Eligibility Criteria

Age40 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.

You may not qualify if:

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.)
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.
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (10)

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, United States

Location

DeLand, Florida, 32720, United States

Location

South Miami, Florida, 33143, United States

Location

St Louis, Missouri, 63141, United States

Location

Edison, New Jersey, 08817, United States

Location

Hato Rey, 00917, Puerto Rico

Location

Brasov, 500366, Romania

Location

Bucharest, 70266, Romania

Location

Iași, 700656, Romania

Location

Târgu Mureş, 540136, Romania

Location

MeSH Terms

Interventions

dasolampanel etibutil

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

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: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 14, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 17, 2012

Results First Posted

October 5, 2011

Record last verified: 2012-04

Locations

PR(1)RO(4)US(5)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (21)

Study Arms (3)

Placebo

LY545694 49 mg

LY545694 105 mg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations