Phase 3
Completed N=151
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Back Pain Lower Back Chronic
Source: ClinicalTrials.gov NCT01914666 ↗
Enrolled (actual)
151
Serious AEs
5.3%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's — 42; 16; 18; 4 participants
Summary
The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's |
42; 16; 18; 4; 3; 1 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 |
-3.30; -3.79; -2.88; -4.16; -4.71; -3.24 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-Improvement) to Week 50 |
2.12; 2.05; 2.61 | — |
| SECONDARY Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50 |
2.09; 2.00; 2.73 | — |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50 |
-3.69; -5.50; -3.29 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 |
10.60; 9.52; 10.12; 16.88; 11.31; 7.01 | — |
| SECONDARY Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50 |
0.16; 0.15; 0.11 | — |
| SECONDARY Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50 |
-1.81; -1.83; -0.56 | — |
| SECONDARY Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Fall Events From Fall Questionnaire |
13; 5; 6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01914666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.