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OpenTrials
Completed

NCT Number: NCT01914666

An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).

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Key information

Conditions

Back Pain Lower Back Chronic

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

Administered orally

Other names: Cymbalta, LY248686

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50

    Time frame: Baseline, 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.

  2. Patient Global Impression of Improvement (PGI-Improvement) to Week 50

    Time frame: 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).

  3. Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50

    Time frame: Baseline, 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).

  4. Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50

    Time frame: Baseline, 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).

  5. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50

    Time frame: Baseline, 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.

  6. Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50

    Time frame: Baseline, 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.

  7. Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50

    Time frame: Baseline, 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.

  8. Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52

    Time frame: Baseline, Week 53

    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.

  9. Number of Participants With Fall Events From Fall Questionnaire

    Time frame: Week 53

    Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Shionogi

Registry information

Official study title

Phase 3 Clinical Study of Duloxetine Hydrochloride in Patients With CLBP - Open Label Long Term Extension Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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