An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT02234583|
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain Associated With Fibromyalgia||Drug: DS-5565||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2485 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia|
|Actual Study Start Date :||February 4, 2015|
|Actual Primary Completion Date :||April 19, 2017|
|Actual Study Completion Date :||April 19, 2017|
Participants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.
DS-5565 15 mg tablet for oral administration
Other Name: Investigational product
- Average Daily Pain Score (ADPS) for DS-5565 [ Time Frame: Day 0 (baseline) up to to Week 52 postdose ]Average of daily pain scores are reported by the participant and 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 Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change [ Time Frame: Week 52 postdose ]Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" status are reported.
- Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565 [ Time Frame: Day 0 (baseline) up to Week 52 postdose ]The HADS questionnaire is a 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 from 0 to 3, where higher scores indicate greater anxiety or depression. 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.
- EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565 [ Time Frame: Day 0 (baseline) up to Week 52 postdose ]The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. 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 0 indicating worst health and 100 representing best imaginable health.
- Short Form-36 (SF-36) Measure for DS-5565 [ Time Frame: Day 0 (baseline) to Week 52 postdose ]The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 physical component summary and mental component summary scales range from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) total scores at baseline and Week 52 are reported.
- Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565 [ Time Frame: Day 0 (baseline) up to Week 52 postdose ]Pain-associated sleep interference was 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). ADSIS is the mean value of all available recordings of the respective week. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.
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): NCT02234583
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|