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To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milnacipran Added | Experimental |
| |
| No Treatment Added | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Treatment Added | Drug | No added treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) Responder Rate at End of Study | The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1. | End of Randomized treatment period (11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain). | Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia D'Astoli | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Birmingham | Alabama | 35205 | United States | ||
| Forest Investigative Site |
Participants entered an open label pregabalin period concurrent with prohibited medication washout. Incomplete responders to pregabalin were randomized to receive either milnacipran (100 mg/d) or no added treatment for 11 weeks. All participant continued background stable dose pregabalin (300 or 450 mg/d) throughout the randomized treatment period.
Participants were recruited and enrolled in this study within the US from December 2008 to June 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment Added | No treatment added for 11 weeks of randomized treatment period |
| FG001 | Milnacipran Added | Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Milnacipran Added | Drug | Milnacipran 100 mg/d added |
|
| Mesa |
| Arizona |
| 85210 |
| United States |
| Forest Investigative Site | Peoria | Arizona | 85381 | United States |
| Forest Investigative Site | Hot Springs | Arkansas | 71913 | United States |
| Forest Investigative Site | Anaheim | California | 92801 | United States |
| Forest Investigative Site | Sacramento | California | 95821 | United States |
| Forest Investigative Site | Sacramento | California | 95825 | United States |
| Forest Investigative Site | Torrance | California | 90505 | United States |
| Forest Investigative Site | Walnut Creek | California | 94598 | United States |
| Forest Investigative Site | Denver | Colorado | 80239 | United States |
| Forest Investigative Site | Cromwell | Connecticut | 06416 | United States |
| Forest Investigative Site | Danbury | Connecticut | 06810 | United States |
| Forest Investigative Site | Clearwater | Florida | 33765 | United States |
| Forest Investigative Site | Daytona Beach | Florida | 32117 | United States |
| Forest Investigative Site | Delray Beach | Florida | 33484 | United States |
| Forest Investigative Site | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site | Miami | Florida | 33169 | United States |
| Forest Investigative Site | Ocala | Florida | 34471 | United States |
| Forest Investigative Site Orl2 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site | Orlando | Florida | 32806 | United States |
| Forest Investigative Site | Ormond Beach | Florida | 32174 | United States |
| Forest Investigative Site PP1 | Pembroke Pines | Florida | 33024 | United States |
| Forest Investigative Site PP2 | Pembroke Pines | Florida | 33029 | United States |
| Forest Investigative Site | Pismo Beach | Florida | 93449 | United States |
| Forest Investigative Site | St. Petersburg | Florida | 33709 | United States |
| Forest Investigative Site | Tampa | Florida | 33614 | United States |
| Forest Investigative Site | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Forest Investigative Site | Couer D'Alene | Idaho | 83814 | United States |
| Forest Investigative Site | Evansville | Indiana | 47713 | United States |
| Forest Investigative Site | Indianapolis | Indiana | 46254 | United States |
| Forest Investigative Site | Indianapolis | Indiana | 46260 | United States |
| Forest Investigative Site | Baltimore | Maryland | 21208 | United States |
| Forest Investigative Site | No. Dartmouth | Massachusetts | 02747 | United States |
| Forest Investigative Site | Worcester | Massachusetts | 01610 | United States |
| Forest Investigative Site | Jackson | Mississippi | 39202 | United States |
| Forest Investigative Site | St Louis | Missouri | 63141 | United States |
| Forest Investigative Site | Omaha | Nebraska | 68134 | United States |
| Forest Investigative Site | Albuquerque | New Mexico | 87108 | United States |
| Forest Investigative Site | Syracuse | New York | 13210 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site | Cleveland | Ohio | 44122 | United States |
| Forest Investigative Site | Eugene | Oregon | 97404 | United States |
| Forest Investigative Site | Medford | Oregon | 97504 | United States |
| Forest Investigative Site | Portland | Oregon | 97210 | United States |
| Forest Investigative Site | Greer | South Carolina | 29651 | United States |
| Forest Investigative Site | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site | Houston | Texas | 77074 | United States |
| Forest Investigative Site | Houston | Texas | 77104 | United States |
| Forest Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Forest Investigative Site | Salt Lake City | Utah | 84102 | United States |
| Forest Investigative Site | Salt Lake City | Utah | 84106 | United States |
| Forest Investigative Site | Woodstock | Vermont | 05091 | United States |
| Forest Investigative Site | Bellevue | Washington | 98004 | United States |
| Forest Investigative Site | Bellingham | Washington | 98226 | United States |
| Forest Investigative Site SEA1 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site SEA2 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site | Spokane | Washington | 99204 | United States |
| Forest Investigative Site | Racine | Wisconsin | 53406 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Treatment Added | No treatment added for 11 weeks of randomized treatment period |
| BG001 | Milnacipran Added | Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number | participants |
| |||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Global Impression of Change (PGIC) Responder Rate at End of Study | The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1. | All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment. | Posted | Number | participants | End of Randomized treatment period (11 weeks) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain). | Posted | Least Squares Mean | Standard Error | mm | Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) |
|
|
Treatment emergent adverse events, defined as adverse events which occurred or worsened after starting randomized study drug, were collected from December 2008 to November 2009.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Treatment Added | No treatment added for 11 weeks of randomized treatment period | 6 | 178 | 38 | 178 | ||
| EG001 | Milnacipran Added | Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period | 5 | 184 | 90 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Inverteral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Palmer, MD | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. | 1-201-427-8218 | robert.palmer@frx.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Title | Measurements |
|---|---|
|
| Male |
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