We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Pain Associated With Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02187159
First Posted: July 10, 2014
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
INC Research
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
  Purpose
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects 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 Intervention Phase
Pain Associated With Fibromyalgia Drug: DS-5565 Drug: Pregabalin Drug: Placebo tablet Drug: Placebo capsule Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Change from baseline in weekly average daily pain score (ADPS) at Week 13 for either dose of DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    Weekly ADPS is based on daily pain scores reported by the patient 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.


Secondary Outcome Measures:
  • Number of participants who answered "much improved or better" on the Patient Global Impression of Change (PGIC) scale at Week 13 receiving either dose of DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    Participants rate PGIC on a categorical scale from 1 = very much improved to 7 = very much worse

  • Change in fibromyalgia index questionnaire (FIQ) total score from baseline to Week 13 in subjects 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 patient 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 will be collected from participants who complete the assessment at Week 13.

  • Number of 50% Responders at Week 13 among participants receiving either dose of DS-5565 or placebo [ Time Frame: Baseline, Week 13 ]
    Number of patients with at least a 50% reduction in ADPS in Week 13 compared to baseline period (50% Responders). Baseline period is the week prior to randomization.

  • Change from baseline in weekly ADPS at Week 13 for either dose of DS-5565 versus pregabalin [ Time Frame: Baseline, Week 13 ]
    Weekly ADPS is based on daily pain scores reported by the patient 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.

  • Number of 30% Responders at Week 13 among participants receiving either dose of DS-5565 or placebo [ Time Frame: Baseline, Week 13 ]
    Number of participants with at least a 30% reduction in ADPS in Week 13 compared to baseline period (30% Responders). Baseline period is the week prior to randomization.

  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) measure, DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4- point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.

  • Change from Baseline in Short Form 36 (SF-36) measure, DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    The SF-36 is a generic health survey that asks 36 questions to measure functional health and well-being from the patient's point of view. It is a practical, reliable, and valid measure of physical and mental health widely used across various disease areas, including FM. The SF-36 provides scores for 8 health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) as well as psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.

  • Change from Baseline in EuroQol five dimensions questionnaire (EQ-5D) measure, DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    The EQ-5D is a well-standardized instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in FM. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with zero indicating worst health and 100 representing best imaginable health.

  • Change from Baseline in Pain-associated Sleep Interference, DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    Pain-associated sleep interference will be assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). The diary is to be filled out every day, along with the pain diary question, from the start of the Baseline Period through the last day on blinded study drug (including the morning following the last dose of blinded study medication).

  • Change from Baseline in the Brief Pain Inventory Short Form (BPI-SF) measure, DS-5565 versus placebo [ Time Frame: Baseline, Week 13 ]
    The BPI-SF has been used in many clinical studies across a wide variety of chronic pain conditions, including FM. This instrument measures pain severity and interference within the past 24 hours. Each item is rated on an 11-point NRS from 0 to 10.

  • Percentage of days a rescue medication was used [ Time Frame: Baseline, Week 13 ]
    Number of days rescue medication used divided by total number of study days


Enrollment: 1270
Actual Study Start Date: November 2014
Study Completion Date: July 11, 2016
Primary Completion Date: July 11, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DS-5565 QD
Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening
Drug: DS-5565
DS-5565 15 mg tablet for oral administration
Other Name: mirogabalin
Drug: Placebo tablet
Placebo tablet (matching DS5565) for oral administration
Other Name: Placebo matching DS-5565
Drug: Placebo capsule
Placebo capsule (matching pregabalin) for oral administration
Other Name: Placebo matching pregabalin
Experimental: DS-5565 BID
Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)
Drug: DS-5565
DS-5565 15 mg tablet for oral administration
Other Name: mirogabalin
Drug: Placebo capsule
Placebo capsule (matching pregabalin) for oral administration
Other Name: Placebo matching pregabalin
Active Comparator: Pregabalin
Participants take one pregabalin capsule and one placebo tablet BID
Drug: Pregabalin
Pregabalin 150 mg capsule for oral administration
Other Name: Lyrica
Drug: Placebo tablet
Placebo tablet (matching DS5565) for oral administration
Other Name: Placebo matching DS-5565
Placebo Comparator: Placebo
Participants take one each of placebo tablet and capsule BID
Drug: Placebo tablet
Placebo tablet (matching DS5565) for oral administration
Other Name: Placebo matching DS-5565
Drug: Placebo capsule
Placebo capsule (matching pregabalin) for oral administration
Other Name: Placebo matching pregabalin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). 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.
  Contacts and Locations
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): NCT02187159


  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85027
Scottsdale, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Fresno, California, United States, 93710
Glendale, California, United States, 91204
Orange, California, United States, 92868
Oxnard, California, United States
Richmond, California, United States, 94806
Sacramento, California, United States
San Diego, California, United States, 92103
Santa Ana, California, United States, 92705
Santa Barbara, California, United States, 93108
Simi Valley, California, United States, 93065
United States, Connecticut
New London, Connecticut, United States
United States, Florida
Bradenton, Florida, United States, 34208
Brandon, Florida, United States, 33511
DeBary, Florida, United States, 32713
Fort Myers, Florida, United States, 33916
Hialeah, Florida, United States, 33013
Homestead, Florida, United States, 33030
Lake Mary, Florida, United States
Miami, Florida, United States, 33126
North Miami, Florida, United States, 33161
Ocala, Florida, United States, 34471
Plant City, Florida, United States, 33563
Tampa, Florida, United States, 33614
United States, Georgia
Alpharetta, Georgia, United States, 30005
Atlanta, Georgia, United States, 30328
Atlanta, Georgia, United States, 30342
Columbus, Georgia, United States, 31904
Savannah, Georgia, United States, 31405
United States, Idaho
Boise, Idaho, United States, 83713
Meridian, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60611
Gurnee, Illinois, United States, 60031
Naperville, Illinois, United States, 60563
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Iowa
West Des Moines, Iowa, United States, 50266
United States, Kansas
Shawnee, Kansas, United States, 66218
Wichita, Kansas, United States, 67205
United States, Kentucky
Lexington, Kentucky, United States, 40509
United States, Louisiana
Monroe, Louisiana, United States, 71201
United States, Michigan
Traverse City, Michigan, United States, 49684
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Nebraska
Omaha, Nebraska, United States, 68134
United States, Nevada
Las Vegas, Nevada, United States, 89123
United States, New York
Brooklyn, New York, United States, 11229
Manhasset, New York, United States
New York, New York, United States, 10128
Staten Island, New York, United States, 10312
United States, North Carolina
Benson, North Carolina, United States
Greensboro, North Carolina, United States, 27408
Raleigh, North Carolina, United States, 27609
Salisbury, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cleveland, Ohio, United States, 44122
Columbus, Ohio, United States
Dayton, Ohio, United States, 45424
Garfield Heights, Ohio, United States, 44125
Middleburg Heights, Ohio, United States
Tiffin, Ohio, United States, 44883
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Salem, Oregon, United States, 97301
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Anderson, South Carolina, United States, 29621
Charleston, South Carolina, United States, 29406
Greer, South Carolina, United States, 29650
Rock Hill, South Carolina, United States, 28209
United States, Tennessee
Bristol, Tennessee, United States, 37620
Knoxville, Tennessee, United States, 37919
New Tazewell, Tennessee, United States, 37825
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77070
Houston, Texas, United States, 77089
San Antonio, Texas, United States, 78229
Sealy, Texas, United States, 77474
Sugar Land, Texas, United States, 77479
United States, Utah
Salt Lake City, Utah, United States, 84102
United States, Virginia
Norfolk, Virginia, United States, 23507
Richmond, Virginia, United States, 23294
United States, Washington
Kirkland, Washington, United States, 98033
United States, West Virginia
Charleston, West Virginia, United States, 25304
Australia, New South Wales
Camperdown, New South Wales, Australia
Campsie, New South Wales, Australia, 2194
Coffs Harbour, New South Wales, Australia, 2450
St. Leonards, New South Wales, Australia
Australia, Queensland
Maroochydore, Queensland, Australia, 4558
Sherwood, Queensland, Australia
Southport, Queensland, Australia, 4215
Australia, South Australia
Woodsville, South Australia, Australia
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Clayton, Victoria, Australia
Malvern East, Victoria, Australia, 3145
Bulgaria
Burgas, Bulgaria
Pleven, Bulgaria
Plovdiv, Bulgaria
Ruse, Bulgaria
Sevlievo, Bulgaria
Sofia, Bulgaria
Targovishte, Bulgaria
Varna, Bulgaria
Estonia
Tallin, Estonia
Tartu, Estonia, 51013
Hungary
Balassagyarmat, Hungary
Budapest, Hungary
Debrecen, Hungary
Esztergom, Hungary
Kistarcsa, Hungary
Nyiregyhaza, Hungary
Szeged, Hungary
Veszprem, Hungary
India
Ahmedabad, Gujarat, India
Surat, Gujarat, India
Bangalore, Karnataka, India
Hubli, Karnataka, India
Pune, Maharashtra, India
Jaipur, Rajasthan, India
Lucknow, VP, India
Latvia
Baldone, Latvia, LV-2155
Balvi, Latvia
Jekabpils, Latvia, LV-5201
Liepaja, Latvia, LV-3401
Ogre, Latvia, LV-5001
Riga, Latvia
Ventspils, Latvia
New Zealand
Auckland, New Zealand, 2025
Hamilton, New Zealand, 3204
Nelson, New Zealand, 7010
Tauranga, New Zealand, 3110
Wellington, New Zealand, 6242
Romania
Bacau, Romania
Bucharest, Romania
Cluj Napoca, Romania
Oradea, Romania
Targu Mures, Romania
Russian Federation
Ivanovo, Russian Federation
Krasnoyarsk, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorod, Russian Federation
Orenburgsky, Russian Federation
Pyatigorski, Russian Federation
St. Petersburg, Russian Federation
Stavropol, Russian Federation
Vladikavkaz, Russian Federation
Yaroslav, Russian Federation
Slovakia
Banska Bystrica, Slovakia, 974 04
Bratislava, Slovakia, 821 08
Dubnica Nad Vahom, Slovakia, 018 41
Galanta, Slovakia
Krompachy, Slovakia
Piestany, Slovakia
Presov, Slovakia
United Kingdom
Reading, Berkshire, United Kingdom, RG7 3SQ
Penzance, Cornwall, United Kingdom
Chesterfield, Derbyshire, United Kingdom, S40 4AA
Poole, Dorset, United Kingdom
Romford, Essex, United Kingdom
Blackpool, Lancashire, United Kingdom
Thornton-cleveleys, Lancashire, United Kingdom
Wigan, Lancashire, United Kingdom
Salford, Manchester, United Kingdom
Southport, Merseyside, United Kingdom
Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
Barnsley, South Yorkshire, United Kingdom
Cannock, Staffordshire, United Kingdom
North Shields, Tyne and Wear, United Kingdom
Atherstone, Warwickshire, United Kingdom, CV9 1EU
Dudley, West Midlands, United Kingdom
Belfast, United Kingdom, BT7 2EB
Leeds, United Kingdom
Manchester, United Kingdom
Torpoint, United Kingdom
Sponsors and Collaborators
Daiichi Sankyo, Inc.
INC Research
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
  More Information

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02187159     History of Changes
Other Study ID Numbers: DS5565-A-E311
2013-005163-10 ( EudraCT Number )
First Submitted: July 8, 2014
First Posted: July 10, 2014
Last Update Posted: October 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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