Trial · NCT01552057

A Study of Duloxetine in Fibromyalgia

NCT01552057, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-12-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Duloxetine in Fibromyalgia. Trials, record NCT01552057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01552057

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Duloxetine in Fibromyalgia
NCT number: NCT01552057
Status: Completed
Phases: Phase 3
Enrollment: 393 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Fibromyalgia
Interventions: Duloxetine 60 mg, Placebo
First posted: 2012-03-13
Last updated: 2015-01-16
Results first posted: 2014-12-19

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	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.
Primary	Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	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.
Primary	Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	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.
Primary	Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	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.
Primary	Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	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.
Primary	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)	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.
Secondary	Patients Global Impression of Improvement (PGI-I) at Endpoint	14 weeks	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.
Secondary	Clinical Global Impression of Improvement (CGI-I) at Endpoint	14 weeks	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.
Secondary	Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)	Baseline, 14 weeks	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.
Secondary	Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores	Baseline, up to 14 weeks	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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	Baseline, 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patients Global Impression of Improvement (PGI-I) at Endpoint	14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression of Improvement (CGI-I) at Endpoint	14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)	Baseline, 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores	Baseline, up to 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)	Baseline, 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	Baseline, 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary	Baseline, 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	Baseline, 14 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	Baseline, 2 weeks	Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	Duloxetine 60 mg		-1.90	Standard Error 0.23	units on a scale
Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)	Placebo		-1.58	Standard Error 0.23	units on a scale
Patients Global Impression of Improvement (PGI-I) at Endpoint	Duloxetine 60 mg		2.83	Standard Error 0.16	units on a scale
Patients Global Impression of Improvement (PGI-I) at Endpoint	Placebo		3.32	Standard Error 0.16	units on a scale
Clinical Global Impression of Improvement (CGI-I) at Endpoint	Duloxetine 60 mg		2.83	Standard Error 0.15	units on a scale
Clinical Global Impression of Improvement (CGI-I) at Endpoint	Placebo		3.27	Standard Error 0.16	units on a scale
Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)	Duloxetine 60 mg		-18.41	Standard Error 2.57	units on a scale
Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)	Placebo		-13.05	Standard Error 2.65	units on a scale
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores	Duloxetine 60 mg	Physical Functioning	7.40	Standard Error 2.13	units on a scale
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores	Placebo	Physical Functioning	3.06	Standard Error 2.15	units on a scale

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Duloxetine 60 mg	196
Overall Study	STARTED	Placebo	197
Overall Study	Received at Least 1 Dose of Study Drug	Duloxetine 60 mg	194
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	196
Overall Study	COMPLETED	Duloxetine 60 mg	166
Overall Study	COMPLETED	Placebo	149
Overall Study	NOT COMPLETED	Duloxetine 60 mg	30
Overall Study	NOT COMPLETED	Placebo	48

Source ClinicalTrials.gov

Adverse events332

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Duloxetine 60 mg	1	194	1
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	196	0
other	Palpitations	Cardiac disorders	Duloxetine 60 mg	5	194	5
other	Palpitations	Cardiac disorders	Placebo	1	196	1
other	Tachycardia	Cardiac disorders	Duloxetine 60 mg	1	194	1
other	Tachycardia	Cardiac disorders	Placebo	1	196	1
other	Tinnitus	Ear and labyrinth disorders	Duloxetine 60 mg	1	194	1
other	Tinnitus	Ear and labyrinth disorders	Placebo	1	196	1
other	Vertigo	Ear and labyrinth disorders	Duloxetine 60 mg	4	194	4
other	Vertigo	Ear and labyrinth disorders	Placebo	0	196	0

1 to 10 of 332Source ClinicalTrials.gov

See all 332 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Duloxetine 60 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Duloxetine 60 mg	147	194
Total, other adverse events	Placebo	122	196
Total, serious adverse events	Duloxetine 60 mg	1	194
Total, serious adverse events	Placebo	1	196

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26296539	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Duloxetine 60 mg vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01552057

GET https://conductscience.org/api/trials/v1/NCT01552057/results?page=2

API reference For AI assistants