Trial · NCT02234583
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
NCT02234583, Phase 3, Completed, Daiichi Sankyo; results first posted 2020-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia. Trials, record NCT02234583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02234583
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
- NCT number
- NCT02234583
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,485 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Pain Associated With Fibromyalgia
- Interventions
- DS-5565
- First posted
- 2014-09-09
- Last updated
- 2020-07-23
- Other registries' IDs
- eudract:2013-005164-26
- Results first posted
- 2020-07-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Daily Pain Score (ADPS) for DS-5565 | 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. |
| Secondary | 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 | 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. |
| Secondary | Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565 | 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. |
| Secondary | EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565 | 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. |
| Secondary | Short Form-36 (SF-36) Measure for DS-5565 | 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. |
| Secondary | Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Daily Pain Score (ADPS) for DS-5565 | Day 0 (baseline) up to to Week 52 postdose | Average daily pain score was assessed in the Safety Analysis Set. | score on a scale | MEAN |
| SECONDARY | 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 | Week 52 postdose | Patient Global Impression of Change was assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565 | Day 0 (baseline) up to Week 52 postdose | HADS-Depression and Anxiety was assessed in the Safety Analysis Set. | score on a scale | MEAN |
| SECONDARY | EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565 | Day 0 (baseline) up to Week 52 postdose | EQ-5D was assessed in the Safety Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short Form-36 (SF-36) Measure for DS-5565 | Day 0 (baseline) to Week 52 postdose | SF-36 was assessed in the Safety Analysis Set. | score on a scale | MEAN |
| SECONDARY | Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565 | Day 0 (baseline) up to Week 52 postdose | Average Daily Sleep Interference Score was assessed in the Safety Analysis Set. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Daily Pain Score (ADPS) for DS-5565 | Rollover DS-5565 15 mg QD Modal | Baseline | 4.77 | Standard Deviation 2.23 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | Rollover DS-5565 15 mg BID Modal | Baseline | 5.58 | Standard Deviation 2.22 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | De Novo DS-5565 15 mg QD Modal | Baseline | 7.08 | Standard Deviation 1.40 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | De Novo DS-5565 15 mg BID Modal | Baseline | 7.38 | Standard Deviation 1.37 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | Rollover DS-5565 15 mg QD Modal | Week 13 | 3.47 | Standard Deviation 2.11 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | Rollover DS-5565 15 mg BID Modal | Week 13 | 4.36 | Standard Deviation 2.32 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | De Novo DS-5565 15 mg QD Modal | Week 13 | 3.21 | Standard Deviation 2.20 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | De Novo DS-5565 15 mg BID Modal | Week 13 | 4.06 | Standard Deviation 2.37 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | Rollover DS-5565 15 mg QD Modal | Week 24 | 3.28 | Standard Deviation 2.08 | score on a scale |
| Average Daily Pain Score (ADPS) for DS-5565 | Rollover DS-5565 15 mg BID Modal | Week 24 | 4.24 | Standard Deviation 2.35 | score on a scale |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DS-5565 15 mg QD Modal | 847 | |
| Overall Study | STARTED | DS-5565 15 mg BID Modal | 1,241 | |
| Overall Study | COMPLETED | DS-5565 15 mg QD Modal | 434 | |
| Overall Study | COMPLETED | DS-5565 15 mg BID Modal | 685 | |
| Overall Study | NOT COMPLETED | DS-5565 15 mg QD Modal | 413 | |
| Overall Study | NOT COMPLETED | DS-5565 15 mg BID Modal | 556 |
Source ClinicalTrials.gov
Adverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | DS-5565 15 mg QD Modal | 43 | 847 | |
| other | Upper respiratory tract infection | Infections and infestations | DS-5565 15 mg BID Modal | 134 | 1,241 | |
| other | Urinary tract infection | Infections and infestations | DS-5565 15 mg QD Modal | 51 | 847 | |
| other | Urinary tract infection | Infections and infestations | DS-5565 15 mg BID Modal | 107 | 1,241 | |
| other | Nasopharyngitis | Infections and infestations | DS-5565 15 mg QD Modal | 47 | 847 | |
| other | Nasopharyngitis | Infections and infestations | DS-5565 15 mg BID Modal | 110 | 1,241 | |
| other | Sinusitis | Infections and infestations | DS-5565 15 mg QD Modal | 36 | 847 | |
| other | Sinusitis | Infections and infestations | DS-5565 15 mg BID Modal | 89 | 1,241 | |
| other | Dizziness | Nervous system disorders | DS-5565 15 mg QD Modal | 134 | 847 | |
| other | Dizziness | Nervous system disorders | DS-5565 15 mg BID Modal | 148 | 1,241 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DS-5565 15 mg QD Modal | 3 | 847 |
| Total, all-cause mortality | DS-5565 15 mg BID Modal | 2 | 1,241 |
| Total, other adverse events | DS-5565 15 mg QD Modal | 669 | 847 |
| Total, other adverse events | DS-5565 15 mg BID Modal | 1,056 | 1,241 |
| Total, serious adverse events | DS-5565 15 mg QD Modal | 41 | 847 |
| Total, serious adverse events | DS-5565 15 mg BID Modal | 94 | 1,241 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31284771 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DS-5565 15 mg QD Modal vs DS-5565 15 mg BID Modal: deaths from any cause | Trial comparisons |
| DS-5565 15 mg QD Modal vs DS-5565 15 mg BID Modal: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02234583
GET https://conductscience.org/api/trials/v1/NCT02234583/results?page=2