Trial record 39 of 111 for:    fibromyalgia | Open Studies | Interventional Studies

Treatment of Pain Associated With Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Daiichi Sankyo Inc.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02146430
First received: May 21, 2014
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

DS 5565 will be better than placebo (sugar pill without active drug) in managing fibromyalgia pain and will be well tolerated.


Condition Intervention Phase
Pain Associated With Fibromyalgia
Drug: DS-5565 15mg tablet
Drug: 150mg pregabalin capsule
Drug: placebo tablet
Drug: placebo capsule
Drug: 75mg pregabalin capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 in weekly average daily pain score (ADPS), DS-5565 versus placebo [ Time Frame: baseline (week 0) to week 13 ] [ Designated as safety issue: No ]
    The primary objective 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.


Secondary Outcome Measures:
  • change in ADPS from baseline to Week 13, DS-5565 versus pregabalin [ Time Frame: baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]
    To compare change in ADPS from baseline to Week 13 in subjects receiving either dose of DS-5565 versus pregabalin

  • proportion of responders at week 13, DS-5565 versus placebo [ Time Frame: baseline (week 0) to Week 13. ] [ Designated as safety issue: No ]
    To compare the proportion of subjects receiving either dose of DS-5565 versus placebo who meet fixed definitions of response (i.e. ≥ 30% or ≥ 50% reduction from baseline to Week 13 in ADPS)

  • change in patient global impression measure, DS-5565 versus placebo [ Time Frame: baseline (week 0) to Week 13. ] [ Designated as safety issue: No ]

    To assess the effects of either dose of DS-5565 versus placebo on patient global impression of change (PGIC).

    This standard instrument is a well-validated outcome measure for pain treatment and shows close correlation with the 11-point pain intensity NRS in the setting of chronic pain. The 7-point PGIC measures change in the subject's overall status using the following categorical scale: 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, and 7) very much worse.


  • change in FIQ measure, DS-5565 versus placebo [ Time Frame: Baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]

    To evaluate the effects of either dose of DS-5565 versus placebo on the fibromyalgia (FM) Impact Questionnaire (FIQ).

    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 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 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.


  • change in MFI-20 measure, DS-5565 versus placebo [ Time Frame: baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]

    To evaluate the effects of either dose of DS-5565 versus placebo on fatigue as assessed by the Multidimensional Fatigue Inventory (MFI-20).

    The Multidimensional Fatigue Inventory (MFI) is a validated 20-item, self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an X in 1 of 5 boxes arranged linearly and anchored by "yes, that is true" at one pole to "no, that is not true" at the opposite pole. The MFI-20 is a brief measure of fatigue that appears to capture relevant dimensions of fatigue severity and offers great clarification of the type of fatigue being experienced and good assessment and precision. It has been used successfully in clinical trials of FM and appears to be a good marker of illness.


  • change in HADS measure, DS-5565 versus placebo [ Time Frame: baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]

    To evaluate the effects of either dose of DS-5565 versus placebo on depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS).

    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 in SF-36 measure, DS-5565 versus placebo [ Time Frame: baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]

    To assess the effects of either dose of DS-5565 versus placebo on subject general health status as assessed by the Short Form 36 (SF-36) questionnaire.

    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 in EQ-5D measure, DS-5565 versus placebo [ Time Frame: baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]

    To assess the effects of either dose of DS-5565 versus placebo on subject quality of life as assessed by the EuroQoL Instrument 5 Domains (EQ-5D).

    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 in pain-associated sleep interference, DS-5565 versus placebo [ Time Frame: baseline (week 0) to week 13 ] [ Designated as safety issue: No ]

    To assess the effects of either dose of DS-5565 versus placebo on pain-associated sleep interference as assessed by average daily sleep interference score (ADSIS) and the Medical Outcomes Study (MOS) Sleep Scale.

    Pain-associated sleep interference will be assessed using electronic daily diaries using an 11-point NRS 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 in BPI-SF measure, DS-5565 versus placebo [ Time Frame: baseline (week 0) to week 13 ] [ Designated as safety issue: No ]

    To assess the effects of either dose of DS-5565 versus placebo on pain as assessed by the Brief Pain Inventory Short Form (BPI-SF).

    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.


  • number and severity of adverse events [ Time Frame: enrollment through week 18 ] [ Designated as safety issue: Yes ]
    All clinical AEs occurring after the subject has signed the ICF and up to 4 weeks after the last dose of study medication (i.e. the follow-up period), whether observed by the investigator or reported by the subject, will be recorded on the AE eCRF page. Medical conditions (including laboratory values/vital signs that are out of range) that exist prior to Informed Consent will be recorded as part of medical history.

  • proportion of days a rescue medication was used [ Time Frame: baseline (week 0) to Week 13 ] [ Designated as safety issue: No ]
    number of days rescue medication used divided by total number of study days


Estimated Enrollment: 1200
Study Start Date: July 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DS-5565, once daily at bedtime
one 15mg DS-5565 tablet taken orally at bedtime
Drug: DS-5565 15mg tablet Drug: placebo tablet
matching DS-5565 tablet
Drug: placebo capsule
matching pregabalin capsule
Experimental: DS-5565, twice daily
one 15mg DS-5565 tablet taken twice daily. (titrated from 15 mg once daily after 1 week); during the first week subject will take DS-5565 placebo in the morning.
Drug: DS-5565 15mg tablet Drug: placebo capsule
matching pregabalin capsule
Active Comparator: Pregabalin 150 mg capsule twice daily
One pregabalin 150 mg capsule taken orally in the morning and one pregabalin 150 mg capsule taken orally at bedtime for 13 weeks (during the first week of blinded-treatment, subjects will take one pregabalin 75 mg capsule in the morning and one pregabalin 75 mg capsule at bedtime
Drug: 150mg pregabalin capsule Drug: placebo tablet
matching DS-5565 tablet
Drug: 75mg pregabalin capsule
Placebo Comparator: placebo
One placebo tablet and one placebo capsule taken orally in the morning and one placebo tablet and one placebo capsule taken orally at bedtime daily for 13 weeks
Drug: placebo tablet
matching DS-5565 tablet
Drug: placebo capsule
matching pregabalin capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02146430

Contacts
Contact: INC Research SM_DS5565_FM_Info@incresearch.com

Sponsors and Collaborators
Daiichi Sankyo Inc.
INC Research
Investigators
Study Director: Domenico Merante, MD Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02146430     History of Changes
Other Study ID Numbers: DS5565-A-E309
Study First Received: May 21, 2014
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

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
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 14, 2014