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CTRI Number  CTRI/2015/05/005805 [Registered on: 25/05/2015] Trial Registered Prospectively
Last Modified On: 19/11/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Double blind trial which has 3 arms- Study drug (DS-5565), Placebo (substance with no therapeutic effect) and Active control . Safety and efficacy (produce desired effect) will be checked on subjects with pain associated with Fibromyalgia. 
Scientific Title of Study   A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in subjects with Pain Associated with Fibromyalgia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT02187159  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shoaib Mohammad 
Designation  Medical Director 
Affiliation  INC Research CDS Services Pvt. Ltd.  
Address  Building No. 14, Tower-B, 14th Floor DLF Cyber City, Phase III

Gurgaon
HARYANA
122001
India 
Phone  9818587766  
Fax  01244642401  
Email  Shoaib.Mohammad@INCResearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shoaib Mohammad 
Designation  Medical Director 
Affiliation  INC Research CDS Services Pvt. Ltd.  
Address  Building No. 14, Tower-B, 14th Floor DLF Cyber City, Phase III

Gurgaon
HARYANA
122001
India 
Phone  9818587766  
Fax  01244642401  
Email  Shoaib.Mohammad@INCResearch.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mamta Singh 
Designation  Associate Director - SSU &RA  
Affiliation  INC Research CDS Services Pvt. Ltd. 
Address  Building No. 14, Tower-B, 14th Floor DLF Cyber City, Phase III

Gurgaon
HARYANA
122001
India 
Phone  01244642449  
Fax  01244642401  
Email  mamta.singh@INCResearch.com  
 
Source of Monetary or Material Support  
Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, NJ, 08837, United States. AND Daiichi Sankyo Development Limited, Chiltern Place, Chalfont Park, Gerrards Cross, Buckinghamshire SL9 0BG, United Kingdom 
 
Primary Sponsor  
Name  Daiichi Sankyo Pharma Development AND Daiichi Sankyo Development Limited 
Address  399 Thornall Street, Edison, NJ, 08837, United States. AND Daiichi Sankyo Development Limited, Chiltern Place, Chalfont Park, Gerrards Cross, Buckinghamshire SL9 0BG, United Kingdom 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
INC Research CDS Services Private Limited   Floor No. 14, Tower B, Buidling no. 14, DLF cybercity, Phase III, Gurgaon - 122001, Haryana 
 
Countries of Recruitment     Australia
Bulgaria
Croatia
Estonia
Hungary
India
Latvia
Lithuania
New Zealand
Romania
Russian Federation
Slovakia
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himanshu Panchal  B J Medical College  D/4, Department of Orthopedics,Haripura, Asarwa Ahmedabad- 380016, Gujarat, India Ahmadabad
Ahmadabad
GUJARAT 		 9825463696

drhimanshupanchal@gmail.com 
Dr Somesh Prakash Singh  GMERS Medical College & Hospital  Room No 5, Department of Orthopedics, OPD Building, Near Gujarat High Court, S.G. Highway, Ahmedabad- 380060, Gujarat
Ahmadabad
GUJARAT 		 9824031850

drsomeshsingh@yahoo.com 
Dr Harvinder Singh Chhabra  Indian Spinal Injury Centre  Sector-C, Vasant Kunj, New Delhi-110070, India
New Delhi
DELHI 		 9958903390

drhschhabra@isiconline.org 
Dr Nachiket J Kulkarni   Jehangir Clinical Development Centre Pvt. Ltd  Rheumatology Department, Jehangir Hospital Premises, 32 Sassoon Road
Pune
MAHARASHTRA 		 9923243860

startup@jcdc.co.in 
Dr Siddharth Kumar Das  King George Medical University, Rheumatology  Rheumatology Department, RALC Campus, Lucknow-226018, UP, India
Lucknow
UTTAR PRADESH 		 9335902776

rheumatologykgmu@gmail.com 
Dr Naresh Shetty  M S Ramaiah Medical College & Hospitals  Department of Orthopedics, MSRIT Post, New BEL Road, Bangalore-560054, Karnataka, India
Bangalore
KARNATAKA 		 9844050222

Nareshs8@hotmail.com 
Dr Bhagawana Ram   Malpani Multispeaciality Hospital  Rheumatology Department,SP-6, Road No -1, VKI Area, Sikar road
Jaipur
RAJASTHAN 		 9460891205

dr.bagaria@yahoo.co.in 
Dr Bankim Desai  Nirmal Hospital Pvt Ltd  Ring Road, Civil Street, Near Kadiwala school
Surat
GUJARAT 		 982513607

drbankim.desai@gmail.com 
Dr Vikram Haridas  Sushruta Multispeciality Hospital & Research Center Private Limited  Room no. 314, P. B. Road Vidyanagar, Hubli-580021, Karnataka, India.
Bangalore
KARNATAKA 		 9343649883

drvikramharidas@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee, M S Ramaiah Medical College & Hospitals  Approved 
Ethics Committee-GMERS Medical College & Sola Civil Hospital  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee of King George Medical University  Approved 
Institutional Ethics Committee, B.J Medical College and Civil Hospital  Submittted/Under Review 
Institutional Ethics Committee, Indian Spinal Injuries  Submittted/Under Review 
Nirmal Hospital Private Ethics Committee  Approved 
Sushruta Hospitals Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pain associated with fibromyalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DS5565  Arm 1: DS5565 15 mg once daily (QD) Arm 2:DS5565 15 mg twice daily (BID) however during the first week of treatment, all subjects randomized to DS-5565 (regardless of dose) will receive 15 mg QD. Route of adminstration is Oral and total Duration of therapy is 13 weeks. 
Comparator Agent  Placebo  Route of Administration is Oral and Total duration of therapy is 13 weeks 
Comparator Agent  Pregabalin  Pregabalin 150 mg BID however during the first week of treatment, all subjects randomized to pregabalin will receive 75 mg BID. Route of Administration is Oral and Total duration of therapy is 13 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age more than or equal 18 years
2. Able to give written informed consent
3. Able to complete subject-reported questionnaires per the investigator’s judgment
4. 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) more than or equal 7 and symptom severity (SS) scale score more than or equal 5, or WPI 3 to 6 and SS scale score more than or equal 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
5. ADPS of more than or equal 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)
6. Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening.
7. 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 
 
ExclusionCriteria 
Details  1. 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
2. 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
3. Unable to undergo pre-study washout of prohibited concomitant medications

4. 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.

5. Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) interview (Version 6.0) at screening are excluded, but 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.

6. Any diagnosis of lifetime bipolar disorder or psychotic disorder

7. 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.

8. Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.

9. Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year

10. Any history of a malignancy other than basal cell carcinoma within the past 5 years

11. A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months

12. Known hypersensitivity to alpha2-delta 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.

13. Pregnancy or breast-feeding, or intent to become pregnant during the study period

14. 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.

15. Subject is an employee of the study center, an immediate family member of an employee of the study center or an employee of Daiichi Sankyo, INC Research or any of the study vendors supporting this study (spouse, parent, child, or sibling, whether biological or legally adopted)
16. 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.

17. Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values judged by the investigator to be clinically significant at screening.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy endpoint is change in weekly ADPS from baseline to Week 13 (Visit 11) for 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.  Primary endpoint: Change in weekly ADPS from baseline to Week 13 (Visit 11) for either dose of DS-5565 versus placebo; weekly ADPS is based on daily pain scores reported by subject best describing his or her worst pain over previous 24 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare Change in ADPS from baseline to Week 13 in subjects receiving either dose of DS-5565 versus pregabalin
Proportion of subjects with greater than 30 percent reduction from baseline to Week 13 in ADPS receiving either dose of DS-5565 versus placebo
Proportion of subjects with greater than 50 percent reduction from baseline to Week 13 in ADPS receiving either dose of DS-5565 versus placebo
To assess the effects of either dose of DS-5565 versus placebo on PGIC at Week 13 		 Key Secondary Endpoints: Change from baseline to Week 13 in subjects receiving either dose of DS-5565 versus pregabalin in ADPS, in proportion of subjects with ≥ 30% reduction in ADPS, in proportion of subjects with ≥ 50% reduction in ADPS, effects on PGIC, in FIQ total score; Remaining secondary endpoints: Changes from baseline to Week 13 for either dose of DS-5565 versus placebo in MFI-20 parameters, in HADS depression and anxiety scores, in SF-36  
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   24/08/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/11/2014 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a randomized, double-blind, double-dummy, placebo- and active controlled, multi-center study of DS-5565 in subjects with pain associated with FM. Eligible subjects will be randomized in the ratio of 1:1:1:1 to receive 13 weeks of treatment with DS-5565 15 mg once daily (QD), DS-5565 15 mg twice daily (BID), placebo, or pregabalin 150 mg BID. During the first week of treatment, all subjects randomized to DS-5565 (regardless of dose) will receive 15 mg QD and all subjects randomized to pregabalin will receive 75 mg BID. Subjects randomized to DS-5565 15 mg QD will continue to receive 15 mg QD for the remaining 12 weeks, subjects randomized to DS-5565 15 mg BID will receive 15 mg BID for the remaining 12 weeks, and subjects randomized to pregabalin 150 mg BID will receive pregabalin 150 mg BID for the remaining 12 weeks. After Week 13 (Visit 11), there will be a 1-week, double-blind tapering period during which subjects randomized to pregabalin 150 mg BID will be tapered off and all other subjects will receive placebo. Subjects completing this study may be eligible to transition into a separate 52-week safety study.  
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