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.
- Conditions
- Pain associated with fibromyalgia
- Registration Number
- CTRI/2015/05/005805
- Lead Sponsor
- Daiichi Sankyo Pharma Development AND Daiichi Sankyo Development Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 1200
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values judged by the investigator to be clinically significant at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (9)
B J Medical College
🇮🇳Ahmadabad, GUJARAT, India
GMERS Medical College & Hospital
🇮🇳Ahmadabad, GUJARAT, India
Indian Spinal Injury Centre
🇮🇳Delhi, DELHI, India
Jehangir Clinical Development Centre Pvt. Ltd
🇮🇳Pune, MAHARASHTRA, India
King George Medical University, Rheumatology
🇮🇳Lucknow, UTTAR PRADESH, India
M S Ramaiah Medical College & Hospitals
🇮🇳Bangalore, KARNATAKA, India
Malpani Multispeaciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
Nirmal Hospital Pvt Ltd
🇮🇳Surat, GUJARAT, India
Sushruta Multispeciality Hospital & Research Center Private Limited
🇮🇳Bangalore, KARNATAKA, India
B J Medical College🇮🇳Ahmadabad, GUJARAT, IndiaDr Himanshu PanchalPrincipal investigator9825463696drhimanshupanchal@gmail.com