An Extension Study of Duloxetine in Osteoarthritis and Kn... | NCT02335346

NCT02335346

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
F1J-JE-HMHD	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Name	Class
Shionogi	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duloxetine	Experimental	Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.	Drug: Duloxetine

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug	Administered orally	Duloxetine	LY248686

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)	A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.	Baseline through Week 53

Secondary Outcomes

Measure	Description	Time Frame
Patient Global Impression-Improvement (PGI-I) at 50 Weeks	Patient Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).	Week 50
Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(Consecutive Participants)

Participants who have completed the 15-week treatment in the preceding study HMGX.

(New Participants)

Participants with present osteoarthritis (OA) based on American College of Rheumatology (ACR) classification of idiopathic OA of the knee.
Have pain for ≥14 days of each month for 3 months prior to study entry.
Have a score of ≥4 on the BPI average pain score at the start of the study.

(Consecutive and New Participants)

Females of child-bearing potential must test negative (-) on a pregnancy test.

Exclusion Criteria:

(New Participants)

Participants who have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
Participants who have major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview (M.I.N.I.).
Participants who have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 1 week.
Participants who have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee or osteotomy at any time.
Participants have a prior synovial fluid analysis showing a white blood cell (WBC) ≥2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.
Participants who have a history of having more than one medical allergy.
Are non-ambulatory or require the use of crutches or a walker.
Have frequent falls that could result in hospitalization or could compromise response to treatment.
Have a history of drug abuse or dependence within the past year, including alcohol and excluding nicotine and caffeine.
Have a positive urine drug screen for any substances of abuse or excluded medication.
Have received administration of another investigational drug within the 30 days prior to enrollment.
Have had previous exposure to duloxetine or completed/withdrawn from any study investigating duloxetine.

(Consecutive and New Participants)

Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory, or hematologic illness, peripheral vascular disease, or other medical condition or neuropsychiatric conditions or clinically significant laboratory abnormalities or electrocardiographic abnormalities.
Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) higher than 100 international units per liter (IU/L) or total bilirubin higher than 1.6 milligrams/deciliter (mg/dL).
Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis.
Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and Type 1 diabetes).
Participants who have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.
Participants who have end stage bone disease or surgery planned during the trial for the index joint.
Participants treated with a monoamine oxidase inhibitor (MAO) within 14 days prior to baseline, or those with the potential need to use MAO inhibitor during the study or within 5 days of discontinuation of investigational drug.
Participants who answer 'yes' to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia-Suicide Severity Rating Scale, suicide ideation section-questions 4 and 5; suicidal behaviors section).
Have a primary painful condition that may interfere with assessment of the index joint, i.e., knee.
Pregnant participants, female participants who wish to be pregnant during the clinical study period, or participants who are breast-feeding; or male participants who wish pregnancy of the partner.
Participants who cannot use appropriate contraceptive method or do not want to use that from the start of the study until one month after the end of administration of the investigational drug.
Considered as inappropriate participation to the study for any medical or other reason by the investigator.

Contacts/Locations Module

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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.		Kobe		650-0046

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Duloxetine	Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00093 subjects
Received At Least 1 Dose of Study Drug		FG00093 subjects
COMPLETED		FG00081 subjects
NOT COMPLETED		FG00012 subjects

Type	Comment	Reasons
Adverse Event		FG00011 subjects
Withdrawal by Subject		FG0001 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Duloxetine	Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)

A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.

All enrolled participants who received at least one dose of study drug.

Posted

Number

Percentage of participants

Baseline through Week 53

ID	Title	Description
OG000	Duloxetine	Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Duloxetine	Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D020370	Osteoarthritis, Knee

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Intervention Browse Module

ID	Term
D000068736	Duloxetine Hydrochloride

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Masking Info

Units	Counts
Participants	OG00093

EG0001 events1 affected93 at risk

Title	Measurements
	OG000-3.33± 1.81

Title	Measurements
	OG00021.32± 21.15