Osteoarthritis Knee PainPhase 3NCT00945945

A Study of Duloxetine in Patients With Osteoarthritis Knee Pain

A Phase 3 study testing Duloxetine (DLX) in people with Osteoarthritis Knee Pain, run by Eli Lilly and Company at 26 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis Knee Pain
What is being tested?: Duloxetine (DLX)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 424 participants
Where: 26 sitesin 8 countries
Study dates: Jul 2009to May 2010
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female outpatients with osteoarthritis knee pain for greater than or equal to 14 days of each month for 3 months prior to study entry.
Have a rating of greater than or equal to 4 on the BPI average pain item (Question 3 of the Brief Pain Inventory [BPI] modified short form) at screening and randomization

Who cannot join

Have had any previous exposure to duloxetine.
Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
Have Major Depression Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, as assessed by the Mini International Neuropsychiatric Interview (Sheehan et al. 1998), or diagnosed within the past year.
Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Are taking any excluded medications that cannot be discontinued at screening visit.
Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.

Show all 25Show fewer

Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
Have a positive urine drug screen for any substance of abuse or excluded medication.
Are pregnant or breast-feeding.
Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
Have a history of recurrent seizures other than febrile seizures.
Are judged by the investigator to be at suicidal risk.
Have uncontrolled narrow-angle glaucoma.
Have acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C).
Have known hypersensitivity to duloxetine or any of the inactive ingredients or patients with frequent or severe allergic reactions to multiple medications.
Have frequent falls that could result in hospitalization or could compromise response to treatment.
Have a confounding painful condition that may interfere with assessment of the index joint, that is, knee. (Knee pain should be the predominant pain. Mild OA pain of other joints is allowed.)
Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
Have received intraarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 3 months.
Have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee at anytime.
Have surgery planned during the study for the index joint.
Have a body mass index (BMI) over 40.
Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve stimulation (TENS), or similar procedures aimed to relieve any kind of pain.
Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to non-steroidal anti-inflammatory drugs(NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study.
Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.

Trial locations and contacts

26 sites in 8 countries.

Country

City, postcode or hospital

26 sites in 8 countries

United States10 sites

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
Clinton, Utah, 84015
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
Lake Jackson, Texas, 77566
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Montgomery, Alabama, 36117
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Morton Grove, Illinois, 60053
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Myrtle Beach, South Carolina, 29572
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Oregon, Wisconsin, 53575
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Phoenix, Arizona, 85050
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Prairie Village, Kansas, 66206
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Spring Valley, California, 91978
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Toledo, Ohio, 43623

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Greece4 sites

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
Heraklion, 71110
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Kifissia, 14561
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Marousi Attikis, 15126
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Thessaloniki, 54639

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Spain4 sites

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A Coruña, 15006
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Barcelona, 08025
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Getafe, 28905
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Madrid, 28009

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Germany3 sites

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
Berlin, 10629
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Hamburg, 22143
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Rhaunen, 55624

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Sweden2 sites

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Malmö, 211 52
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Uddevalla, SE45150

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Puerto Rico1 site

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Ponce, 00716

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Romania1 site

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Bucharest, 020125

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Russia1 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
Moscow, 117997

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About this study

Official title: A Phase 3b Study to Assess the Efficacy of Duloxetine 60 mg Once Daily Compared With Placebo on the Reduction of Pain Caused by Osteoarthritis of the Knee, in a 13-week, Double-blind, Randomized Study

The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.

Conditions: Osteoarthritis Knee Pain
Being tested: Duloxetine (DLX), Placebo (PLA)
Keywords: Osteoarthritis, Knee, Pain
Medical subject headings: Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duloxetine (DLX)Drug
Also called LY248686, Cymbalta
dose daily by mouth
Placebo (PLA)Drug
Placebo Comparator daily by mouth

Study groups in NCT00945945
Study group	Role	What they receive
DLX30-PLA	Experimental	Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol. Receives: Drug: Duloxetine (DLX); Drug: Placebo (PLA)
PLA-DLX60	Placebo comparator	Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol. Receives: Drug: Duloxetine (DLX); Drug: Placebo (PLA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented.
Measured: Baseline, 13 weeks

Secondary outcomes (10)

Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale
C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: 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: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Measured: Baseline through 13 weeks
Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score
The WOMAC index (pain, stiffness, physical function subscales) was completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale
Self-reported scale measuring pain severity. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Four questions assess worst pain, least pain, and average pain in the past 24 hours, and pain right now. Total score ranges from 0-40. Due to the nature of a study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score
Interference scores range from 0 (does not interfere) to 10 (completely interferes) on 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Total score ranges from 0-70. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version
An 11-item questionnaire to individually and jointly assess intermittent and constant pain. Questions assess intensity and impact of pain on activity and emotion. Each item is scored from 0 to 4; higher values indicate higher severity. Total Pain score ranges from 0-44. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)
BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0-20. Total score = sum of all factor scores minus vigor score. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)
Patients rate their health state in 5 domains: mobility, self-care, usual activities, pain, and mood. Score between 1-3 is generated for each domain which is mapped to single index score. Index ranges between 0-1; higher scores indicate better health perceived by patient. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks
Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey
Self-reported questionnaire with 36 questions covering 8 health domains. 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. Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.
Measured: Baseline, 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009May 2010

First posted24 Jul 2009 (estimated)
Study startJul 2009
Primary completionMay 2010
Study completionMay 2010

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 Osteoarthritis Knee PainStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 424 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00945945
Sponsor's protocol ID: 13214
Other IDs: F1J-MC-HMGP
Status last verified: Feb 2011
First submitted: 23 Jul 2009
Last updated: 8 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain

All Osteoarthritis Knee Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b Study to Assess the Efficacy of Duloxetine 60 mg Once Daily Compared With Placebo on the Reduction of Pain Caused by Osteoarthritis of the Knee, in a 13-week, Double-blind, Randomized Study
ClinicalTrials.gov ID: NCT00945945
Acronym / sponsor ID: 13214
Conditions: Osteoarthritis Knee Pain
Keywords: Osteoarthritis, Knee, Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 424 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 24 Jul 2009 (estimated)
Results: Posted 8 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DLX30-PLA	Experimental	Drug: Duloxetine (DLX), Drug: Placebo (PLA)Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
PLA-DLX60	Placebo comparator	Drug: Duloxetine (DLX), Drug: Placebo (PLA)Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female outpatients with osteoarthritis knee pain for greater than or equal to 14 days of each month for 3 months prior to study entry.
Have a rating of greater than or equal to 4 on the BPI average pain item (Question 3 of the Brief Pain Inventory [BPI] modified short form) at screening and randomization

Key exclusion criteria (25 listed)

Have had any previous exposure to duloxetine.
Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
Have Major Depression Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, as assessed by the Mini International Neuropsychiatric Interview (Sheehan et al. 1998), or diagnosed within the past year.
Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Are taking any excluded medications that cannot be discontinued at screening visit.

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
Duloxetine (DLX)Also: LY248686, Cymbaltadose daily by mouth	Drug	DLX30-PLA, PLA-DLX60
Placebo (PLA)Placebo Comparator daily by mouth	Drug	DLX30-PLA, PLA-DLX60

Primary outcome

Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
Time frame: Baseline, 13 weeks
A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented.

10 secondary outcomes

Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale
Time frame: Baseline through 13 weeks
Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score
Time frame: Baseline, 13 weeks
Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score
Time frame: baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale
Time frame: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score
Time frame: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)
Time frame: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version
Time frame: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)
Time frame: Baseline, 13 weeks
Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)
Time frame: Baseline, 13 weeks
Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey
Time frame: Baseline, 13 weeks

Results and safety

Results posted to the registry on 8 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DLX30-PLA	207	171
PLA-DLX60	217	162

Primary outcome: Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score

Time frame: Baseline, 13 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	DLX30-PLA n = 207	PLA-DLX60 n = 217
Baseline	6.00 (1.28)	6.10 (1.31)
Change from Baseline to Endpoint (BOCF)	-1.93 (2.23)	-2.34 (2.30)

DLX30-PLA vs PLA-DLX60: Least Squares Mean Difference: 0.34 (95% CI -0.07 to 0.75), p = 0.105, ANCOVA

Population analysed: Number of randomized participants with a non-missing baseline and BOCF endpoint.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DLX30-PLA	3 of 207 (1.4%)	105 of 207 (50.7%)	Not reported
PLA-DLX60	2 of 217 (0.9%)	143 of 217 (65.9%)	Not reported

Limitations and caveats (from the sponsor): Due to a package labeling error, study drug was incorrectly administered to all patients in both treatment groups. This compromised the integrity of the entire study and rendered planned comparisons between duloxetine and placebo invalid.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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

26 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duloxetine (DLX) in people with Osteoarthritis Knee Pain, run by Eli Lilly and Company at 26 sites in 8 countries.

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 2 inclusion and 25 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 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Greece, Spain, Germany, Sweden and 3 more countries. 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. Some participants in this study may receive a placebo. 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 8 Mar 2011). 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?

Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score (time frame: Baseline, 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00945945.

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 8 Mar 2011.