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Treatment of Pain Associated With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02187471
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo.

Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.


Condition or disease Intervention/treatment Phase
Pain Associated With Fibromyalgia Drug: DS-5565 Drug: Pregabalin Drug: Placebo tablet Drug: Placebo capsule Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
Actual Study Start Date : October 2014
Actual Primary Completion Date : January 6, 2017
Actual Study Completion Date : January 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants take one each of placebo tablet and capsule, twice daily (BID)
Drug: Placebo tablet
Placebo tablet for oral use, matching DS-5565 tablet
Other Name: Tablet Control

Drug: Placebo capsule
Placebo capsule for oral use, matching pregabalin capsule
Other Name: Capsule Control

Pregabalin
Participants take one pregabalin capsule and one placebo tablet BID
Drug: Pregabalin
Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule
Other Name: Other treatment - not comparator

Drug: Placebo tablet
Placebo tablet for oral use, matching DS-5565 tablet
Other Name: Tablet Control

Experimental: DS-5565 15 mg QD
Participants take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet once daily (QD)
Drug: DS-5565
DS-5565 15 mg QD or BID; tablet for oral use
Other Name: Mirogabalin

Drug: Placebo tablet
Placebo tablet for oral use, matching DS-5565 tablet
Other Name: Tablet Control

Drug: Placebo capsule
Placebo capsule for oral use, matching pregabalin capsule
Other Name: Capsule Control

Experimental: DS-5565 15 mg BID
Participants take one placebo capsule with one DS-5565 tablet BID
Drug: DS-5565
DS-5565 15 mg QD or BID; tablet for oral use
Other Name: Mirogabalin

Drug: Placebo capsule
Placebo capsule for oral use, matching pregabalin capsule
Other Name: Capsule Control




Primary Outcome Measures :
  1. Average daily pain score (ADPS) for either dose of DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    Average daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain. For participants with no Week 13 data, the baseline observation was carried forward (BOCF).


Secondary Outcome Measures :
  1. Number of participants who answered "much improved or better" in PGIC at Week 13 receiving either dose of DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    Participants rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse

  2. Average score on the fibromyalgia index questionnaire (FIQ) in participants receiving either dose of DS-5565 or placebo [ Time Frame: Baseline, Week 13 ]
    The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4-point Likert-type scale. Items 2 and 3 ask the participant to mark the number of days that they feel well and the number of days they were unable to work (including housework) because of fibromyalgia (FM) symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. A higher score indicates a greater impact of the syndrome on the patient. Scores were collected from participants who completed the assessment at the given time point.

  3. Number of participants receiving either dose of DS-5565 or placebo classified as responders at Week 13 [ Time Frame: Baseline, Week 13 ]
    Participants classified as responders are those with a substantial reduction in ADPS in Week 13 (BOCF) compared to baseline.

  4. Average daily pain score (ADPS) for pregabalin [ Time Frame: Baseline, Week 13 ]
    Average daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain. For participants with no Week 13 data, the baseline observation was carried forward (BOCF).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Able to give written informed consent
  • Able to complete subject-reported questionnaires per the investigator's judgment
  • At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
  • Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
  • Symptoms have been present at a similar level for at least 3 months
  • The subject does not have a disorder that would otherwise explain the pain
  • ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)
  • Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening.
  • Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion.

Exclusion Criteria:

  • Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months prior to screening that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
  • Anticipation of initiation or significant change to normal daily exercise routines or need for ongoing use of concomitant medications or non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety
  • Unable to undergo pre-study washout of prohibited concomitant medications
  • Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Patients answering "yes" to any of the C-SSRS questions at screening must be excluded. Such patients should be referred immediately to a mental health professional for appropriate evaluation.
  • Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study.
  • Any diagnosis of lifetime bipolar disorder or psychotic disorder
  • Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM.
  • Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
  • Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
  • Any history of a malignancy other than basal cell carcinoma within the past 5 years
  • A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
  • Pregnancy or breast-feeding, or intent to become pregnant during the study period
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
  • Known hypersensitivity to alpha2-delta (α2δ) ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.
  • Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study.
  • Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values judged by the investigator to be clinically significant at screening, with particular focus on: a. Abnormal renal function defined as calculated creatinine clearance (CrCl) < 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen> 1.5 × upper limit of normal (ULN); creatine kinase > 3.0 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 μmol/L); b. Abnormal liver function defined as aspartate aminotransferase (AST) > 2.0 × ULN, alanine aminotransferase (ALT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187471


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Locations
United States, Alabama
Birmingham, Alabama, United States, 35242
Huntsville, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States, 85020
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
United States, California
Anaheim, California, United States
Covina, California, United States, 91723
El Cajon, California, United States, 92020
Encino, California, United States
Huntington Beach, California, United States, 92646
Lakewood, California, United States, 90712
Lomita, California, United States, 90717
Los Angeles, California, United States
National City, California, United States, 91950
Northridge, California, United States, 91324
Oceanside, California, United States
Sacramento, California, United States
Upland, California, United States, 91786
Walnut Creek, California, United States
United States, Florida
Boca Raton, Florida, United States, 33486
DeLand, Florida, United States, 32720
Edgewater, Florida, United States, 32132
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States, 33016
Largo, Florida, United States, 33774
Lauderdale Lakes, Florida, United States, 33319
Maitland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States, 32807
Sunrise, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States, 32960
West Palm Beach, Florida, United States
Winter Haven, Florida, United States
Winter Park, Florida, United States
United States, Georgia
Dawsonville, Georgia, United States
Marietta, Georgia, United States, 30060
Smyrna, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Granger, Indiana, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Kentucky
Owensboro, Kentucky, United States, 423303
United States, Louisiana
Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States, 70119
United States, Maryland
Frederick, Maryland, United States
United States, Massachusetts
Brockton, Massachusetts, United States
North Dartmouth, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States, 48104
Ann Arbor, Michigan, United States
Lansing, Michigan, United States
Rochester Hills, Michigan, United States
United States, Missouri
Florissant, Missouri, United States
Hazelwood, Missouri, United States
O'Fallon, Missouri, United States
United States, Nebraska
Bellevue, Nebraska, United States
United States, New Hampshire
Newington, New Hampshire, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Brooklyn, New York, United States, 11230
Cedarhurst, New York, United States
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, North Dakota
Minot, North Dakota, United States, 58701
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
Media, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
United States, South Carolina
Greenville, South Carolina, United States
Mount Pleasant, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Franklin, Tennessee, United States, 37064
Knoxville, Tennessee, United States, 37912
Memphis, Tennessee, United States
United States, Texas
Austin, Texas, United States, 78756
Houston, Texas, United States, 77024
Lake Jackson, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States, 23235
United States, Washington
Bellevue, Washington, United States, 98007
Richland, Washington, United States, 99352
Argentina
Caba, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Lanús, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
San Fernando, Buenos Aires, Argentina
Rosario, Santa FE, Argentina
Cordoba, Argentina
San Miguel de Tucuman, Argentina
Santa Fe, Argentina
Austria
Klagenfurt, Austria
Senftenberg, Austria, 3541
Vienna, Austria, 1090
Belarus
Minsk, Belarus
Vitebsk, Belarus
Belgium
Brussels, Belgium
Edegem, Belgium
Gozee, Belgium
Oostham, Belgium
Chile
Antofagasta, Chile
Providencia, Chile
Puerto Varas, Chile
Vina Del Mar, Chile
Colombia
Barranquilla, Colombia
Bogota, Colombia
Israel
Haifa, Israel
Kfar Saba, Israel
Ramat Gan, Israel
Tel-aviv, Israel
Mexico
Cuautitlán Izcalli, Mexico
Durango, Mexico
Guadalajara, Mexico
Leon, Mexico
Mexico City, Mexico
Poland
Elblag, Poland
Gdansk, Poland
Katowice, Poland
Kraków, Poland
Lublin, Poland
Nadarzyn, Poland
Nowa Sol, Poland
Torun, Poland
Tychy, Poland
Warsaw, Poland
Portugal
Aveiro, Portugal
Braga, Portugal
Guimaraes, Portugal
Lisboa, Portugal
Ponte de Lima, Portugal
Porto, Portugal
Vila Nova de Gaia, Portugal
Slovenia
Ljubljana, Slovenia
Slovenj Gradec, Slovenia
Spain
Alicante, Spain
Barcelona, Spain
Elche, Spain
Granada, Spain
Guadalajara, Spain
Madrid, Spain
Santiago de Compostela, Spain
Sevilla, Spain
Switzerland
Geneva, Switzerland
St. Gallen, Switzerland
Sponsors and Collaborators
Daiichi Sankyo, Inc.
INC Research
Investigators
Study Director: David Jacobs, MD Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02187471     History of Changes
Other Study ID Numbers: DS5565-A-E310
2013-005162-20 ( EudraCT Number )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

Keywords provided by Daiichi Sankyo, Inc.:
pain
fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs