FibromyalgiaPhase 3NCT01552057
A Study of Duloxetine in Fibromyalgia
A Phase 3 study testing Duloxetine 60 mg in people with Fibromyalgia, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Duloxetine 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 393 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2012to Dec 2013
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
- Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) - average pain severity item (Question 3)
Who cannot join
- Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators
- Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units per liter (IU/L) or total bilirubin of not less than 1.6 milligrams per deciliter (mg/dL)
- Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis
- Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
- Participants with treatment-refractory fibromyalgia
- Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by 3-month or longer drug therapy
Show all 20Show fewer
- Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency
- Participants with an axis I condition according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), currently or within the past year, except for major depressive disorders
- Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator
- Participants with personality disorder or mental retardation
- Participants with uncontrolled angle closure glaucoma
- Participants with present or past history of uncontrolled seizures or convulsion disorders
- Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year
- Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
- Participants with past history of multiple episodes of drug allergy
- Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant
- Females of child-bearing potential who can't agree to utilize medically. acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study
- Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year
- Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis)
- Participants previously treated with duloxetine
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.
Miyagi, 982-0032
About this study
Official title: A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia
The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Duloxetine 60 mg, Placebo
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 60 mgDrug
Also called LY248686, Cymbalta
Duloxetine 60 mg taken orally once every day for 15 weeks
PlaceboDrug
Placebo taken orally once every day for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine 60 mg | Experimental | Duloxetine hydrochloride up to 60 milligrams (mg) orally for 15 weeks Receives: Drug: Duloxetine 60 mg |
| Placebo | Placebo comparator | Placebo orally for 15 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 14 weeks
Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 2 weeks
Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 4 weeks
Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 6 weeks
Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 10 weeks
Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.
Measured: Baseline, up to 14 weeks
Secondary outcomes (8)
Patients Global Impression of Improvement (PGI-I) at Endpoint
PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: 14 weeks
Clinical Global Impression of Improvement (CGI-I) at Endpoint
CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: 14 weeks
Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)
FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.
Measured: Baseline, up to 14 weeks
Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010
WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary
Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Measured: Baseline, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- 393 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
- NCT01552057
- Sponsor's protocol ID
- 14377
- Other IDs
- F1J-JE-HMGZ
- Status last verified
- Jan 2015
- First submitted
- 9 Mar 2012
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murakami M, Osada K, Mizuno H, Ochiai T, Alev L, Nishioka K. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther. 2015 Aug 22;17(1):224. doi: 10.1186/s13075-015-0718-y.
PubMed 26296539
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01552057
- Acronym / sponsor ID
- 14377
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Posted 19 Dec 2014
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 effectiveness and safety of duloxetine in participants with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine 60 mg | Experimental | Drug: Duloxetine 60 mgDuloxetine hydrochloride up to 60 milligrams (mg) orally for 15 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally for 15 weeks |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
- Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) - average pain severity item (Question 3)
Key exclusion criteria (20 listed)
- Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators
- Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units per liter (IU/L) or total bilirubin of not less than 1.6 milligrams per deciliter (mg/dL)
- Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis
- Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
- Participants with treatment-refractory fibromyalgia
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 60 mgAlso: LY248686, CymbaltaDuloxetine 60 mg taken orally once every day for 15 weeks | Drug | Duloxetine 60 mg |
| PlaceboPlacebo taken orally once every day for 15 weeks | Drug | Placebo |
Primary outcome
Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Time frame: Baseline, 14 weeks
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Time frame: Baseline, 2 weeks
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Time frame: Baseline, 4 weeks
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Time frame: Baseline, 6 weeks
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Time frame: Baseline, 10 weeks
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)
Time frame: Baseline, up to 14 weeks
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.
8 secondary outcomes
Patients Global Impression of Improvement (PGI-I) at Endpoint
Time frame: 14 weeks
Clinical Global Impression of Improvement (CGI-I) at Endpoint
Time frame: 14 weeks
Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Time frame: Baseline, up to 14 weeks
Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010
Time frame: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary
Time frame: Baseline, 14 weeks
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Time frame: Baseline, 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26296539Murakami M, Osada K, Mizuno H, Ochiai T, Alev L, Nishioka K. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther. 2015 Aug 22;17(1):224. doi: 10.1186/s13075-015-0718-y.
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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 60 mg in people with Fibromyalgia, 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 2 inclusion and 20 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 16 Jan 2015. 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. 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 19 Dec 2014). 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 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) (time frame: Baseline, 14 weeks). The study lists 6 primary outcomes in all. 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 NCT01552057, which also lists 1 linked publication.
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 16 Jan 2015.