An Open Label Extension Study of Duloxetine (LY248686) in... | NCT01914666

NCT01914666

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-HMHC	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. Tapering week doses of 40 mg for first week and 20 mg for second week.	Drug: Duloxetine

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's	A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.	Week 53

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50	A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(Consecutive Participants):

Participants who have completed the 15-week administration in the phase 3 clinical study of Duloxetine hydrochloride in participants with CLBP, study HMGY (NCT01855919)
Female participants having child-bearing potential must test negative (-) on a pregnancy test

(New Participants):

Participants with CLBP present for the preceding 6 months or longer
Participants used nonsteroidal anti-inflammatory drugs for CLBP for less than 14 days on average per month in the past 3 months and less than 14 days in one month prior to study
Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score at participation of study
Female participants having child-bearing potential must test negative (-) on a pregnancy test

Exclusion Criteria:

(Consecutive Participants):

Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
Participants having primary painful condition due to other than CLBP
Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
Participants answering "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 Behavior section)
Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period
Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug
Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator

(New Participants):

Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 IU/L or total bilirubin higher than 1.6 mg/dL
Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
Participants having primary painful condition due to other than CLBP
Participants having a history of low back surgery
Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview
Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
Participants treating with a MAOI within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
Participants answering "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 Behavior section)
Participants have known hypersensitivity to multiple medications
Participants are non-ambulatory or require the use of crutches or a walker
Participants having a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
Participants having a positive urine drug screen for any substances of abuse
Participants have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine
Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period
Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug
Participants being considered as inappropriate for participation to the study for any medical or other reason as judged 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.		Saitama		330-0063

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	Naïve	New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
FG001	Rollover (Pre-Placebo)	Consecutive participants (randomized to placebo in study F1J-JE-HMGY [NCT#01855919]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
FG002	Rollover (Pre-Duloxetine 60 mg)	Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.

Periods

Title

Milestones

Reasons Not Completed

Treatment Period

Type	Comment	Milestone Data
STARTED		FG00068 subjects FG00142 subjects FG00241 subjects
Received at Least 1 Dose of Study Drug		FG00068 subjects FG00142 subjects FG00241 subjects
COMPLETED		FG00055 subjects FG00136 subjects FG00233 subjects
NOT COMPLETED		FG00013 subjects FG0016 subjects FG0028 subjects

Type	Comment	Reasons
Lack of Efficacy		FG0000 subjects FG0010 subjects FG0022 subjects
Adverse Event		FG000

Tapering Period

Type	Comment	Milestone Data
STARTED		FG00059 subjects4 Pts who discontinued, and 55 Pts who completed Treatment Period entered Tapering Period. FG00139 subjects3 Pts who discontinued, and 36 Pts who completed Treatment Period entered Tapering Period. FG00240 subjects7 Pts who discontinued, and 33 Pts who completed Treatment Period entered Tapering Period.
COMPLETED

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Naïve	New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
BG001	Rollover (Pre-Placebo)

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

Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's

A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

All the enrolled participants who received at least 1 dose of study drug.

Posted

Number

participants

Week 53

ID	Title	Description
OG000	Naïve	New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
OG001	Rollover (Pre-Placebo)	Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.

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	Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)	All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Angle closure glaucoma	Eye disorders	MedDRA 16.1	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	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

No data available

No data is available for this block.

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

Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.

EG0001 events1 affected151 at risk

EG0002 events2 affected151 at risk