Back Pain Lower Back ChronicPhase 3NCT01914666
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
A Phase 3 study testing Duloxetine in people with Back Pain Lower Back Chronic, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
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
About this study
Official title: Phase 3 Clinical Study of Duloxetine Hydrochloride in Patients With CLBP - Open Label Long Term Extension Study
The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Duloxetine
- Keywords
- Chronic Low Back Pain, CLBP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta, LY248686
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 53
Secondary outcomes (9)
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.
Measured: Baseline, Week 50
Patient Global Impression of Improvement (PGI-Improvement) to Week 50
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).
Measured: Week 50
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Measured: Baseline, Week 50
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50
RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).
Measured: Baseline, Week 50
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Measured: Baseline, Week 50
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.
Measured: Baseline, Week 50
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.
Measured: Baseline, Week 50
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Measured: Baseline, Week 53
Number of Participants With Fall Events From Fall Questionnaire
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.
Measured: Week 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914666
- Sponsor's protocol ID
- 14949
- Other IDs
- F1J-JE-HMHC
- Status last verified
- Dec 2015
- First submitted
- 31 Jul 2013
- Last updated
- 27 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Study of Duloxetine Hydrochloride in Patients With CLBP - Open Label Long Term Extension Study
- ClinicalTrials.gov ID
- NCT01914666
- Acronym / sponsor ID
- 14949
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Chronic Low Back Pain, CLBP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Posted 27 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineDuloxetine 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: Cymbalta, LY248686Administered orally | Drug | Duloxetine |
Primary outcome
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
Time frame: Week 53
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
9 secondary outcomes
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Time frame: Baseline, Week 50
Patient Global Impression of Improvement (PGI-Improvement) to Week 50
Time frame: Week 50
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50
Time frame: Baseline, Week 50
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50
Time frame: Baseline, Week 50
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Time frame: Baseline, Week 50
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50
Time frame: Baseline, Week 50
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50
Time frame: Baseline, Week 50
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
Time frame: Baseline, Week 53
Number of Participants With Fall Events From Fall Questionnaire
Time frame: Week 53
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Back Pain Lower Back Chronic, run by Eli Lilly and Company at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's (time frame: Week 53). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.