Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
392 participants
INTERVENTIONAL
2012-11-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TD-9855 Group 1
Group 1 to be dosed with TD-9855
TD-9855 Group 1
TD-9855 Group 2
Group 2 to be dosed with TD-9855
TD-9855 Group 2
Placebo
Group to be dosed with Placebo
Placebo
Interventions
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TD-9855 Group 1
TD-9855 Group 2
Placebo
Eligibility Criteria
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Inclusion Criteria
* Informed consent
* 18 to 65 years of age
* Discontinue therapy with adrenergic-acting drugs, and certain other medications
* Only acetaminophen or NSAID as rescue pain medication
* No narcotic pain meds or benzodiazepines
* Only non-benzodiazepines as rescue hypnotics
Exclusion Criteria
* Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
* Risk of suicide (investigator opinion and/or C-SSRS)
* Recent history of substance or alcohol abuse
* BMI \<18 or ≥45
* Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
* Abnormal lab values (liver, kidney, thyroid, and others)
18 Years
65 Years
ALL
No
Sponsors
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Theravance Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Theravance Biopharma
Locations
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Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
Meridien Research
Lakeland, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
GTC Research
Shawnee Mission, Kansas, United States
Beacon Clinical Research
Brockton, Massachusetts, United States
Beacon Clinical Research
New Bedford, Massachusetts, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Carolina Center for Rheumatology & Arthritis Care
Rock Hill, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Swedish Rheumatology Research
Seattle, Washington, United States
Countries
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References
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Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.
Other Identifiers
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0092
Identifier Type: -
Identifier Source: org_study_id
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