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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02187159




Registration number
NCT02187159
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014

Titles & IDs
Public title
Treatment of Pain Associated With Fibromyalgia
Scientific title
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
Secondary ID [1] 0 0
2013-005163-10
Secondary ID [2] 0 0
DS5565-A-E311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Associated With Fibromyalgia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DS-5565
Treatment: Drugs - Pregabalin
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Placebo capsule

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

Experimental: DS-5565 BID - Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)

Active comparator: Pregabalin - Participants take one pregabalin capsule and one placebo tablet BID

Placebo comparator: Placebo - Participants take one each of placebo tablet and capsule BID


Treatment: Drugs: DS-5565
DS-5565 15 mg tablet for oral administration

Treatment: Drugs: Pregabalin
Pregabalin 150 mg capsule for oral administration

Treatment: Drugs: Placebo tablet
Placebo tablet (matching DS5565) for oral administration

Treatment: Drugs: Placebo capsule
Placebo capsule (matching pregabalin) for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [1] 0 0
Baseline up to Week 13 postdose
Secondary outcome [1] 0 0
Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [1] 0 0
Week 13 postdose
Secondary outcome [2] 0 0
Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [2] 0 0
Baseline up to Week 13 postdose
Secondary outcome [3] 0 0
Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [3] 0 0
Week 13 postdose
Secondary outcome [4] 0 0
Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [4] 0 0
Baseline up to Week 13 postdose
Secondary outcome [5] 0 0
Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [5] 0 0
Baseline up to Week 13 postdose
Secondary outcome [6] 0 0
Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [6] 0 0
Baseline up to Week 13 postdose
Secondary outcome [7] 0 0
Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [7] 0 0
Baseline up to Week 13 postdose
Secondary outcome [8] 0 0
Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [8] 0 0
Baseline up to Week 13 postdose
Secondary outcome [9] 0 0
The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [9] 0 0
Week 13 postdose
Secondary outcome [10] 0 0
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [10] 0 0
Baseline up to Week 13 postdose
Secondary outcome [11] 0 0
Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo
Timepoint [11] 0 0
Week 1 to Week 13 postdose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 (a2d) 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2016
Sample size
Target
Accrual to date
Final
1270
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Campsie
Recruitment hospital [3] 0 0
- Coffs Harbour
Recruitment hospital [4] 0 0
- St. Leonards
Recruitment hospital [5] 0 0
- Maroochydore
Recruitment hospital [6] 0 0
- Sherwood
Recruitment hospital [7] 0 0
- Southport
Recruitment hospital [8] 0 0
- Woodsville
Recruitment hospital [9] 0 0
- Hobart
Recruitment hospital [10] 0 0
- Clayton
Recruitment hospital [11] 0 0
- Malvern East
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
2194 - Campsie
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
- St. Leonards
Recruitment postcode(s) [5] 0 0
4558 - Maroochydore
Recruitment postcode(s) [6] 0 0
- Sherwood
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
- Woodsville
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
- Clayton
Recruitment postcode(s) [11] 0 0
3145 - Malvern East
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Connecticut
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Illinois
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Louisiana
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Michigan
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Yaroslav
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Dubnica Nad Vahom
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Slovakia
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Galanta
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Krompachy
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Slovakia
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Piestany
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Slovakia
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Presov
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United Kingdom
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Berkshire
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Cornwall
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Derbyshire
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Dorset
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Essex
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Lancashire
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Manchester
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Merseyside
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Northamptonshire
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South Yorkshire
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Staffordshire
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Tyne and Wear
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Warwickshire
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WEST Midlands
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Belfast
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Leeds
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Torpoint

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. 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://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
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, the European Union and/or Japan 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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02187159