Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Neurotoxicity, Pain, Peripheral Neuropathy
About this trial
This is an interventional supportive care trial for Neurotoxicity focused on measuring unspecified adult solid tumor, protocol specific, neurotoxicity, pain, peripheral neuropathy
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of cancer
- CNS malignancy allowed with the exception of leptomeningeal carcinomatosis
Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior treatment with single-agent taxane or platinum agents (paclitaxel, docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from both classes)
- CIPN > grade 1 as measured by NCI-CTCAE v 4.0
- Average neuropathic pain score ≥ 4
Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:
- Diabetes mellitus
- Peripheral vascular disease
- HIV infection
- Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy
- No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)
PATIENT CHARACTERISTICS:
- AST ≤ 3 times upper limit of normal
- Total bilirubin ≤ normal
- Creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Able to take oral or enteral medication
- No history of seizure disorder
- No diagnosis of ethanol addiction or dependence within the past 10 years
- No history of narrow-angle glaucoma
None of the following:
- History of suicidal thoughts
- Symptoms of or history of schizophrenia, bipolar disease, or a major depression
- Serious eating disorder such as bulimia or anorexia where electrolyte imbalance is likely
PRIOR CONCURRENT THERAPY:
- At least 3 months since prior and no concurrent taxane or platinum agent
- At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants
- No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine, cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine)
- No concurrent anticonvulsants
No concurrent B or E vitamin supplementation in doses greater than the recommended daily allowance (RDA)
- Centrum (standard formula) and One-A-Day "essential" formula which contain 100% RDA for vitamins B6, E, and B12 allowed
- Other multivitamins allowed provided they contain no more than 100% RDA of B vitamins and vitamin E
- No concurrent treatment (pharmacologic) for depression
Sites / Locations
- Kaiser Permanente - Deer Valley
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants - Castro Valley
- Cancer Care Center at John Muir Health - Concord Campus
- Kaiser Permanente - Fremont
- Valley Medical Oncology
- Glendale Memorial Hospital Comprehensive Cancer Center
- Kaiser Permanente Medical Center - Hayward
- Rebecca and John Moores UCSD Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Contra Costa Regional Medical Center
- Camino Medical Group - Treatment Center
- El Camino Hospital Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- Kaiser Permanente - Division of Research - Oakland
- Kaiser Permanente Medical Center - Oakland
- Palo Alto Medical Foundation
- Kaiser Permanente Medical Center - Rancho Cordova
- Kaiser Permanente Medical Center - Redwood City
- Kaiser Permanente Medical Center - Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente Medical Center - Roseville
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- South Sacramento Cancer Center
- South Sacramento Kaiser-Permanente Medical Center
- Kaiser Permanente Medical Center - Sacramento
- Kaiser Permanente Medical Office -Vandever Medical Office
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- California Pacific Medical Center - California Campus
- Kaiser Permanente Medical Center - Santa Teresa
- Doctors Medical Center - San Pablo Campus
- Kaiser Foundation Hospital - San Rafael
- Sutter Health - Western Division Cancer Research Group
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Kaiser Permanente Medical Center - Santa Rosa
- Kaiser Permanente Medical Center - South San Francisco
- Kaiser Permanente Medical Facility - Stockton
- Kaiser Permanente Medical Center - Vacaville
- Kaiser Permanente Medical Center - Vallejo
- Sutter Solano Medical Center
- Kaiser Permanente Medical Center - Walnut Creek
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Kaiser Permanente - Denver
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Kaiser Permanente - Lafayette
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Bendheim Cancer Center at Greenwich Hospital
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Memorial Cancer Institute at Memorial Regional Hospital
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Cleveland Clinic Florida - Weston
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- John B. Amos Cancer Center
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Kaiser Permanente - Moanalua Medical Center and Clinic
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- John H. Stroger, Jr. Hospital of Cook County
- Resurrection Medical Center
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Elmhurst Memorial Hospital
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Mason District Hospital
- Joliet Oncology-Hematology Associates, Limited - West
- Illinois CancerCare - Kewanee Clinic
- La Grange Memorial Hospital
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- Good Samaritan Regional Health Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Swedish-American Regional Cancer Center
- Illinois CancerCare - Spring Valley
- Regional Cancer Center at Memorial Medical Center
- CCOP - Carle Cancer Center
- Central Dupage Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Michiana Hematology Oncology PC - Plymouth
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- South Bend Clinic
- Michiana Hematology Oncology PC - La Porte
- McFarland Clinic, PC
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cotton-O'Neil Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Cancer Resource Center at King's Daughters Medical Center
- Central Baptist Hospital
- Harold Alfond Center for Cancer Care
- Greenebaum Cancer Center at University of Maryland Medical Center
- Shore Regional Cancer Center at Memorial Hospital - Easton
- Union Hospital Cancer Program at Union Hospital
- Sturdy Memorial Hospital
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Great Lakes Cancer Institute at McLaren Regional Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Breslin Cancer Center at Ingham Regional Medical Center
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Michiana Hematology Oncology PC - Niles
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeside Cancer Specialists, PLLC
- Lakeland Regional Cancer Care Center - St. Joseph
- St. John Macomb Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- St. Luke's Hospital Cancer Care Center
- Fairview Southdale Hospital
- Fergus Falls Medical Group, PA
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Regions Hospital Cancer Care Center
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology Hematology, PA - Woodbury
- Saint Francis Medical Center
- Saint Luke's Hospital
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Midwest Hematology Oncology Group, Incorporated
- St. Anthony's Cancer Center
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- CCOP - St. Louis-Cape Girardeau
- Comprehensive Cancer Care, PC
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- Center for Cancer Care at Exeter Hospital
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Norris Cotton Cancer Center at Catholic Medical Center
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Saint Peter's University Hospital
- Somerset Medical Center
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Cancer Institute of New Jersey at Cooper - Voorhees
- New York Oncology Hematology, PC at Albany Regional Cancer Care
- New York Oncology Hematology, PC at Albany Medical Center
- Amsterdam Community Cancer Program
- Veterans Affairs Medical Center - Brooklyn
- CCOP - Hematology-Oncology Associates of Central New York
- Charles R. Wood Cancer Center at Glens Falls Hospital
- New York Oncology Hematology, PC - Hudson
- Queens Cancer Center of Queens Hospital
- New York Oncology Hematology, PC - Latham
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- Riverview Cancer Care Medical Associates, PC
- Nalitt Cancer Institute at Staten Island University Hospital
- Veterans Affairs Medical Center - Syracuse
- Samaritan Hospital at Northeast Health
- Dickstein Cancer Treatment Center at White Plains Hospital Center
- Waverly Hematology Oncology
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Batte Cancer Center at Northeast Medical Center
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Pardee Memorial Hospital
- High Point Regional Hospital
- Emerywood Hematology/Oncology
- Kinston Medical Specialists
- Iredell Memorial Hospital
- Wake Forest University Comprehensive Cancer Center
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Trinity CancerCare Center
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Mary Rutan Hospital
- Wood County Oncology Center
- Aultman Cancer Center at Aultman Hospital
- Adena Regional Medical Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- North Coast Cancer Care - Clyde
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Bay Area Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Doylestown Hospital Cancer Center
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Geisinger Hazleton Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Cancer Center at Phoenixville Hospital
- Pottstown Memorial Regional Cancer Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Roper St. Francis Cancer Center at Roper Hospital
- McLeod Regional Medical Center
- Bon Secours St. Francis Health System
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- Greenville Hospital Cancer Center
- CCOP - Greenville
- Self Regional Cancer Center at Self Regional Medical Center
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Cancer Centers of the Carolinas - Seneca
- Cancer Centers of the Carolinas - Spartanburg
- Rapid City Regional Hospital
- Brooke Army Medical Center
- Martha Jefferson Hospital Cancer Care Center
- Danville Regional Medical Center
- Fredericksburg Oncology, Incorporated
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Virginia Commonwealth University Massey Cancer Center
- Schiffler Cancer Center at Wheeling Hospital
- Aurora Memorial Hospital of Burlington
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
- Oncology Alliance - Franklin
- Oncology Alliance, SC - Milwaukee - East
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- Mercy Regional Cancer Center
- Oncology Alliance - Kenosha South
- Gundersen Lutheran Center for Cancer and Blood
- Dean Medical Center - Madison
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Vince Lombardi Cancer Clinic - Marinette
- Marshfield Clinic - Marshfield Center
- Aurora Advanced Healthcare East Mequon Clinic
- Aurora Sinai Medical Center
- Medical Consultants, Limited
- Oncology Alliance, SC - Milwaukee - South
- Marshfield Clinic - Lakeland Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Green Bay Oncology, Limited - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Health Center - Racine
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Vince Lombardi Cancer Clinic - Sheboygan
- Marshfield Clinic at Saint Michael's Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Aurora Medical Center
- Vince Lombardi Cancer Clinic - Two Rivers
- Aurora Health Center - Waukesha
- Waukesha Memorial Hospital Regional Cancer Center
- Marshfield Clinic - Wausau Center
- Oncology Alliance, SC - Milwaukee - West
- Aurora Women's Pavilion of West Allis Memorial Hospital
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I/Group A (Duloxetine then Placebo)
Arm II/Group B (Placebo then Duloxetine)
Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.