Trial · NCT02146430
Treatment of Pain Associated With Fibromyalgia
NCT02146430, Phase 3, Completed, Daiichi Sankyo; results first posted 2020-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Pain Associated With Fibromyalgia. Trials, record NCT02146430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02146430
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Pain Associated With Fibromyalgia
- NCT number
- NCT02146430
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,293 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Pain Associated With Fibromyalgia
- Interventions
- DS-5565, Pregabalin, Placebo tablet, Placebo capsule
- First posted
- 2014-05-23
- Last updated
- 2020-11-09
- Other registries' IDs
- eudract:2013-005161-40
- Results first posted
- 2020-11-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo | Baseline up to Week 13 postdose | Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported. |
| Secondary | Number of Participants Who Answered "Much Improved or Better" in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up Week 13 postdose | Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. Higher scores indicate worse outcomes. The number of participants with 'much improved or better' status (≤2) is being reported. |
| Secondary | Change in Fibromyalgia Index Questionnaire (FIQ) Total Score From Baseline to Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome. For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment. |
| Secondary | Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo | Week 13 postdose | The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported. |
| Secondary | Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue). For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue. |
| Secondary | Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | The HADS questionnaire is a reliable, widely-used 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 (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression). |
| Secondary | Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 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 scale ranges 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) scores are reported. |
| Secondary | Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 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) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome. For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health. |
| Secondary | Change From Baseline to Week 13 in Average Daily Sleep Interference in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up Week 13 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. |
| Secondary | 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 | Week 13 postdose | The MOS Sleep Scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), and sleep quantity scale (1 item) were determined. Most subscales range from 0 to 100, where higher scores indicate more of the concept begin measured (eg., higher sleep disturbance scores indicate greater sleep disturbances). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo | Baseline up to Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Answered Much Improved or Better in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Fibromyalgia Index Questionnaire (FIQ) Total Score From Baseline to Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo | Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | This outcome was assessed in the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in Average Daily Sleep Interference in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Week 13 postdose | This outcome was assessed in the modified intent-to-treat analysis set. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo | Placebo | -1.66 | Standard Error 0.132 | units on a scale | |
| Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo | Pregabalin 150 mg BID | -1.90 | Standard Error 0.134 | units on a scale | |
| Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo | DS-5565 15 mg QD | -1.97 | Standard Error 0.134 | units on a scale | |
| Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo | DS-5565 15 mg BID | -1.93 | Standard Error 0.136 | units on a scale | |
| Number of Participants Who Answered Much Improved or Better in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Placebo | 83 | Participants | ||
| Number of Participants Who Answered Much Improved or Better in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Pregabalin 150 mg BID | 105 | Participants | ||
| Number of Participants Who Answered Much Improved or Better in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | DS-5565 15 mg QD | 104 | Participants | ||
| Number of Participants Who Answered Much Improved or Better in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | DS-5565 15 mg BID | 82 | Participants | ||
| Change in Fibromyalgia Index Questionnaire (FIQ) Total Score From Baseline to Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Placebo | -13.20 | Standard Deviation 1.173 | units on a scale | |
| Change in Fibromyalgia Index Questionnaire (FIQ) Total Score From Baseline to Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Pregabalin 150 mg BID | -16.60 | Standard Deviation 1.166 | units on a scale |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 323 | |
| Overall Study | STARTED | Pregabalin 150 mg BID | 323 | |
| Overall Study | STARTED | DS-5565 QD | 324 | |
| Overall Study | STARTED | DS-5565 BID | 323 | |
| Overall Study | Safety Analysis Set | Placebo | 318 | |
| Overall Study | Safety Analysis Set | Pregabalin 150 mg BID | 318 | |
| Overall Study | Safety Analysis Set | DS-5565 QD | 320 | |
| Overall Study | Safety Analysis Set | DS-5565 BID | 320 | |
| Overall Study | Modified Intent to Treat Set (mITT) | Placebo | 318 | |
| Overall Study | Modified Intent to Treat Set (mITT) | Pregabalin 150 mg BID | 317 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events148
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 | Weight increased | Investigations | Placebo | 16 | 318 | 16 |
| other | Weight increased | Investigations | Pregabalin | 36 | 318 | 36 |
| other | Weight increased | Investigations | DS-5565 QD | 21 | 320 | 21 |
| other | Weight increased | Investigations | DS-5565 BID | 36 | 320 | 36 |
| other | Dizziness | Nervous system disorders | Placebo | 20 | 318 | 20 |
| other | Dizziness | Nervous system disorders | Pregabalin | 65 | 318 | 65 |
| other | Dizziness | Nervous system disorders | DS-5565 QD | 53 | 320 | 53 |
| other | Dizziness | Nervous system disorders | DS-5565 BID | 71 | 320 | 71 |
| other | Headache | Nervous system disorders | Placebo | 36 | 318 | 36 |
| other | Headache | Nervous system disorders | Pregabalin | 48 | 318 | 48 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 318 |
| Total, all-cause mortality | Pregabalin | 0 | 318 |
| Total, all-cause mortality | DS-5565 QD | 0 | 320 |
| Total, all-cause mortality | DS-5565 BID | 0 | 320 |
| Total, other adverse events | Placebo | 145 | 318 |
| Total, other adverse events | Pregabalin | 247 | 318 |
| Total, other adverse events | DS-5565 QD | 229 | 320 |
| Total, other adverse events | DS-5565 BID | 251 | 320 |
| Total, serious adverse events | Placebo | 11 | 318 |
| Total, serious adverse events | Pregabalin | 2 | 318 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02146430
GET https://conductscience.org/api/trials/v1/NCT02146430/results?page=2