|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
8 October 2021 |
|
Main ID: |
EUCTR2006-003484-31-FR |
|
Date of registration:
|
16/11/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients with Chronic Low Back Pain - HMEN
|
|
Scientific title:
|
Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients with Chronic Low Back Pain - HMEN |
|
Date of first enrolment:
|
22/12/2006 |
|
Target sample size:
|
230 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003484-31 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
France
|
Germany
|
Netherlands
| | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
•Male or female outpatients at least 18 years of age with chronic low back pain as their primary painful condition.
•Based upon medical history, neurological examination and medical records, have low back pain (T-6 or below) present on most days for the preceding 6 months or longer and fulfill all disease diagnostic criteria).
•Have a weekly mean of 24-hour average pain score greater than or equal to 4 (average of 24-hour pain assessments recorded in the electronic patient diary during the last week before randomization, on a 0 to 10 scale, where 0 is no pain and 10 is worst possible pain).
•Females of child bearing potential must test negative on a pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Provera® Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia & Upjohn), partner with vasectomy, abstinence, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
•Have education level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
•Are judged by the investigator to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
•Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
•Are Lilly or Boehringer Ingelheim (BI) employees.
•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
•Have a history of more than 1 low back surgery.
•Have a history of low back surgery within 12 months prior to study entry.
•Have received epidural steroids, facet block, nerve block or other invasive procedures aimed to reduce low back pain within the past month prior to Visit 1.
•Have previously completed or withdrawn from this study or any other study investigating duloxetine hydrochloride.
•Completion of the daily diaries for less than 70% of the days between Visit 1 and Visit 2.
•Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
•Have major depressive disorder as determined using depression module of the Mini International Neuropsychiatric Interview (MINI).
•Anticipated by the investigator to require use of opioid analgesics or other protocol-excluded medication for the duration of the study.
•Have ongoing or anticipated disability compensation or litigation issues, in the best judgement of the investigator.
•Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures, such as treatment-refractory history.
•Are judged clinically by the investigator to be at suicidal risk or as identified by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II) prior to starting study drug.
•Have a positive urine drug screen for any substances of abuse or excluded medication (including but not limited to narcotics, barbiturates, amphetamines, benzodiazepines).
•Have acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C).
•Have a body mass index (BMI) over 35.
•Have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.
•Have had previous exposure to duloxetine.
•Have 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.
•Have known hypersensitivity to duloxetine, to its inactive ingredients, or to multiple other medications.
•Are taking any excluded medications that cannot be discontinued at Visit 1.
•Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of Visit 2 or the potential need to use and MAOI during the study or within 5 days of discontinuation of study drug.
•Are non-ambulatory or require the use of crutches or a walker.
•Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
•Are pregnant or breast-feeding.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Chronic Low Back Pain
MedDRA version: 8.1
Level: LLT
Classification code 10003988
Term: Back pain
|
|
Intervention(s)
|
Trade Name: Cymbalta
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Cymbalta
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
Secondary Objective: • Evaluate duloxetine 60 to 120 mg QD vs placebo on patients’ perceived improvement.
• Evaluate duloxetine 60 to 120 mg QD vs placebo on the improvement of functioning.
• Assess the efficacy of duloxetine 60 to 120 mg QD vs placebo during the acute treatment phase.
• Assess the impact of treatment with duloxetine 60 to120 mg QD vs placebo during the acute treatment phase on patient-reported health outcomes.
• Evaluate whether reduction in pain is a direct analgesic effect of duloxetine 60 mg QD to 120 mg QD and is independent of treatment effect on mood.
• Evaluate the efficacy of duloxetine 60 mg QD vs placebo.
• Evaluate the safety of duloxetine 60 mg QD to 120 mg QD vs placebo.
• Evaluate the maintenance effect of duloxetine 60 mg QD to 120 mg QD during the extension treatment.
• Assess the safety of duloxetine during the extension phase ondiscontinuation rates, TEAEs, vital signs, and laboratory analytes.
|
|
Primary end point(s): Weekly mean of the 24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
|
Main Objective: The primary objective of this study is to assess the efficacy of duloxetine 60 mg once
daily (QD) to 120 mg QD compared with placebo on the reduction of pain severity as measured by the weekly mean of the 24-hour average pain scores in patients with chronic low back pain (CLBP) during a 13-week, double-blind acute treatment period using an 11-point Likert scale and an electronic patient diary.
|
|
Secondary ID(s)
|
|
F1J-MC-HMEN
|
|
2006-003484-31-NL
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 22/12/2006
Contact:
|
|