Trial · NCT00314249
Study of Milnacipran for the Treatment of Fibromyalgia
NCT00314249, Phase 3, Completed, Forest Laboratories; results first posted 2009-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Milnacipran for the Treatment of Fibromyalgia. Trials, record NCT00314249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00314249
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Milnacipran for the Treatment of Fibromyalgia
- NCT number
- NCT00314249
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,025 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Fibromyalgia
- Interventions
- Placebo, Milnacipran 100mg
- First posted
- 2006-04-13
- Last updated
- 2010-01-20
- Results first posted
- 2009-11-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Syndrome Responder Status | At the end of the three-month stable dose treatment phase | Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS) |
| Primary | Composite Pain Responder Status | At the end of three-month stable dose treatment phase | Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved." |
| Secondary | Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase | Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) | Time-weighted average (area under the curve \[AUC\]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time. PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain). |
| Secondary | Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | Time-weighted average (area under the curve \[AUC\]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time. PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse. |
| Secondary | Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. | Baseline through end of week 12 (Visit TX12) | Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue. MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true." |
| Secondary | Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains \& 2 component summaries (mental and physical); assessing quality of life, health \& functional status. SF-36 PCS: weighted summary of physical function using all 8 domains. Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status. SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase | Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) | The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments for weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF). | units on scale | MEAN |
| SECONDARY | Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF). | units on scale | MEAN |
| SECONDARY | Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. | Baseline through end of week 12 (Visit TX12) | The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments at the end of week 12 (Visit TX12), values were imputed using Last Observation Carried Forward (LOCF). | units on scale | MEAN |
| PRIMARY | Composite Syndrome Responder Status | At the end of the three-month stable dose treatment phase | The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)). | Syndrome Responder Participants | NUMBER |
| PRIMARY | Composite Pain Responder Status | At the end of three-month stable dose treatment phase | The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)). | Pain Responder Participants | NUMBER |
| SECONDARY | Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase, values were imputed using the Last Observation Carried Forward (LOCF) approach. | units on scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase | Placebo | 48.0 | Standard Error 0.83 | units on scale | |
| Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase | Milnacipran | 41.2 | Standard Error 0.87 | units on scale | |
| Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. | Placebo | 3.4 | Standard Error 0.06 | units on scale | |
| Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. | Milnacipran | 2.9 | Standard Error 0.06 | units on scale | |
| Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. | Placebo | -3.96 | Standard Error 0.549 | units on scale | |
| Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. | Milnacipran | -5.50 | Standard Error 0.599 | units on scale | |
| Composite Syndrome Responder Status | Placebo | 56 | Syndrome Responder Participants | ||
| Composite Syndrome Responder Status | Milnacipran | 103 | Syndrome Responder Participants | ||
| Composite Pain Responder Status | Placebo | 90 | Pain Responder Participants | ||
| Composite Pain Responder Status | Milnacipran | 147 | Pain Responder Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 509 | |
| Overall Study | STARTED | Milnacipran | 516 | |
| Overall Study | COMPLETED | Placebo | 357 | |
| Overall Study | COMPLETED | Milnacipran | 353 | |
| Overall Study | NOT COMPLETED | Placebo | 152 | |
| Overall Study | NOT COMPLETED | Milnacipran | 163 |
Source ClinicalTrials.gov
Adverse events68
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 | Constipation | Gastrointestinal disorders | Placebo | 20 | 509 | |
| other | Constipation | Gastrointestinal disorders | Milnacipran | 76 | 516 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 26 | 509 | |
| other | Diarrhoea | Gastrointestinal disorders | Milnacipran | 23 | 516 | |
| other | Dizziness | Nervous system disorders | Placebo | 26 | 509 | |
| other | Dizziness | Nervous system disorders | Milnacipran | 54 | 516 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 31 | 509 | |
| other | Dyspepsia | Gastrointestinal disorders | Milnacipran | 25 | 516 | |
| other | Fatigue | General disorders | Placebo | 22 | 509 | |
| other | Fatigue | General disorders | Milnacipran | 31 | 516 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Milnacipran | ||
| Total, other adverse events | Placebo | 382 | 509 |
| Total, other adverse events | Milnacipran | 434 | 516 |
| Total, serious adverse events | Placebo | 7 | 509 |
| Total, serious adverse events | Milnacipran | 10 | 516 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Milnacipran 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.
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/NCT00314249
GET https://conductscience.org/api/trials/v1/NCT00314249/events?page=2