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Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02496884
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: DS-5565
Drug: Placebo
Enrollment 56
Recruitment Details A total of 56 participants who met all inclusion and no exclusion criteria were randomized to treatment in four countries: Bulgaria, Romania, Spain, and the United States.
Pre-assignment Details Eligible participants were randomized 2:1 to receive either DS-5565 7.5 mg QD or placebo for participants with CrCl 15 to 29 mL/min, or 2:1 to receive treatment with DS-5565 7.5 mg BID or placebo for participants with CrCl 30 to 59 mL/min over a 13-week double-blind treatment period.
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Hide Arm/Group Description Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period. Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period. Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period. Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
Period Title: Overall Study
Started 17 34 1 4
Safety Analysis Set 17 34 1 4
Modified Intent to Treat Set (mITT) 17 34 1 4
Pharmacokinetic (PK) Analysis Set 0 33 0 4
Completed Treatment Per Protocol 16 27 1 3
Completed 15 31 1 4
Not Completed 2 3 0 0
Reason Not Completed
Counted twice as enrolled             2             0             0             0
Withdrawal by Subject             0             3             0             0
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD Total
Hide Arm/Group Description Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period. Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period. Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period. Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD). Total of all reporting groups
Overall Number of Baseline Participants 17 34 1 4 56
Hide Baseline Analysis Population Description
Demographic and baseline characteristics are reported in the Safety Analysis Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 34 participants 1 participants 4 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  47.1%
12
  35.3%
1
 100.0%
1
  25.0%
22
  39.3%
>=65 years
9
  52.9%
22
  64.7%
0
   0.0%
3
  75.0%
34
  60.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 34 participants 1 participants 4 participants 56 participants
64.4  (11.39) 68.4  (13.92) 53.0 74.0  (12.25) 67.3  (13.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 34 participants 1 participants 4 participants 56 participants
Female
16
  94.1%
28
  82.4%
1
 100.0%
0
   0.0%
45
  80.4%
Male
1
   5.9%
6
  17.6%
0
   0.0%
4
 100.0%
11
  19.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 34 participants 1 participants 4 participants 56 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  11.8%
2
   5.9%
0
   0.0%
1
  25.0%
5
   8.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
3
   8.8%
1
 100.0%
1
  25.0%
6
  10.7%
White
14
  82.4%
29
  85.3%
0
   0.0%
2
  50.0%
45
  80.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Average Daily Pain Score (ADPS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 34 participants 1 participants 4 participants 56 participants
ADPS less than 7
8
  47.1%
9
  26.5%
1
 100.0%
2
  50.0%
20
  35.7%
ADPS 7 or more
9
  52.9%
25
  73.5%
0
   0.0%
2
  50.0%
36
  64.3%
[1]
Measure Description: Participants were asked to rate their pain on a scale of 0-10, where 0=no pain and 10=the most pain experienced. The average ADPS at baseline was recorded.
Baseline Average Daily Pain Score (ADPS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 34 participants 1 participants 4 participants 56 participants
6.99  (1.35) 7.21  (0.96) 5.70 6.53  (0.82) 7.07  (1.09)
[1]
Measure Description: Participants were asked to rate their pain on a scale of 0-10, where 0=no pain and 10=the most pain experienced, where higher scores indicate worse outcome. The average ADPS at baseline was recorded.
1.Primary Outcome
Title Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Hide Description

A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state. Relationship of TEAEs to study drug is assessed by the investigator.

Clinically significant changes from baseline in clinical laboratory evaluations, neurological examinations, and electrocardiograms are reported as TEAEs.

Time Frame Baseline up to 30 days after last dose, up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Analysis Set.
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Hide Arm/Group Description:
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
Overall Number of Participants Analyzed 17 34 1 4
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 TEAE
8
  47.1%
16
  47.1%
0
   0.0%
3
  75.0%
Drug-related TEAEs
1
   5.9%
9
  26.5%
0
   0.0%
0
   0.0%
Serious TEAE
0
   0.0%
1
   2.9%
0
   0.0%
0
   0.0%
Drug-related serious TEAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Patients Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS is described as a scale developed at Columbia University that has 2-6 questions each in categories of Suicidal Ideation, Intensity of Ideation, Suicidal Behavior, and Actual Attempts. Four constructs were measured. Severity of Suicidal ideation is rated on a 5-point ordinal scale. Intensity of ideation is comprised of 5 items (frequency, duration, controllability, deterrents, and reason for ideation), each rated on a 5-point ordinal scale. Suicidal behavior is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. Lethality, assesses actual attempts; actual lethality is rated on a 6-point ordinal scale, and if actual lethality is 0, potential lethality of attempts is rated on a 3-point ordinal scale.The higher the C-SSRS score, the higher the suicide risk (ie. worse outcome).
Time Frame Screening up to Week 13 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The C-SSRS score was assessed in the Safety Analysis Set.
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Hide Arm/Group Description:
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
Overall Number of Participants Analyzed 17 34 1 4
Measure Type: Count of Participants
Unit of Measure: Participants
Screening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 13
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Hide Description Each day participants will rate their worst pain over the last 24 hours on a scale from 0-10, where 0=no pain and 10=worst pain imaginable. Each week individual pain scores will be averaged, and the mean weekly score for the treatment group will be calculated. Higher ADPS scores indicate worse outcome.
Time Frame Baseline up to Week 13 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Average daily pain scores were assessed in the modified Intent-to-Treat (mITT) Analysis Set.
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Hide Arm/Group Description:
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
Overall Number of Participants Analyzed 17 34 1 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.99  (1.35) 7.21  (0.96) 5.70 6.53  (0.82)
Week 1 6.26  (1.53) 6.10  (1.63) 2.0 6.88  (0.15)
Week 2 6.03  (1.68) 5.73  (2.06) 1.70 6.60  (0.80)
Week 3 5.77  (1.72) 5.55  (1.94) 1.70 6.80  (0.40)
Week 4 5.41  (1.91) 5.43  (1.99) 1.30 6.75  (0.50)
Week 5 5.45  (1.65) 5.46  (2.08) 0.70 6.90  (0.99)
Week 6 5.16  (1.75) 5.16  (2.18) 1.4 6.43  (1.91)
Week 7 5.03  (2.10) 5.09  (2.14) 1.20 6.67  (1.53)
Week 8 5.15  (2.03) 5.04  (2.23) 1.00 6.73  (1.52)
Week 9 5.09  (1.82) 4.81  (2.24) 1.00 6.47  (1.91)
Week 10 4.86  (2.06) 4.97  (2.20) 0.90 6.53  (1.75)
Week 11 4.28  (1.99) 4.80  (2.31) 0.70 6.73  (1.12)
Week 12 4.17  (2.16) 4.69  (2.20) 0.80 6.63  (2.27)
Week 13 4.28  (2.45) 4.15  (1.84) 1.00 6.80  (2.23)
4.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Scores at Week 13
Hide Description The PGIC is a validated outcome measure for treatment of pain in the acute pain setting. At the end of treatment, participants will rate their overall status on a scale of 1-7, where 1=very much improved and 7=very much worse using the standard PGIC questionnaire. Higher scores indicate worse outcome.
Time Frame Week 13 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Global Impression of Change (PGIC) scores were assessed in the modified Intent-to-Treat (mITT) Analysis Set.
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Hide Arm/Group Description:
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
Overall Number of Participants Analyzed 17 34 1 4
Measure Type: Count of Participants
Unit of Measure: Participants
Score 1-3; Improved
12
  70.6%
20
  58.8%
1
 100.0%
1
  25.0%
Score 4; No change
3
  17.6%
8
  23.5%
0
   0.0%
3
  75.0%
Score 5-7; Worsened
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
1
   5.9%
6
  17.6%
0
   0.0%
0
   0.0%
Time Frame Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
Adverse Event Reporting Description A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
 
Arm/Group Title M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Hide Arm/Group Description Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period. Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period. Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period. Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
All-Cause Mortality
M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/34 (0.00%)   0/1 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   1/34 (2.94%)   0/1 (0.00%)   0/4 (0.00%) 
Nervous system disorders         
Transient ischaemic attack  1  0/17 (0.00%)  1/34 (2.94%)  0/1 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
M-CKD Placebo M-CKD DS-5565 7.5 mg BID S-CKD Placebo S-CKD DS-5565 7.5 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/17 (47.06%)   16/34 (47.06%)   0/1 (0.00%)   3/4 (75.00%) 
Blood and lymphatic system disorders         
Iron deficiency anemia  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Neutrophilia  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Eye disorders         
Dry eye  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Gastrooesophageal reflux disease  1  1/17 (5.88%)  1/34 (2.94%)  0/1 (0.00%)  0/4 (0.00%) 
Nausea  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
General disorders         
Drug withdrawal syndrome  1  0/17 (0.00%)  2/34 (5.88%)  0/1 (0.00%)  0/4 (0.00%) 
Oedema peripheral  1  0/17 (0.00%)  2/34 (5.88%)  0/1 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  1/17 (5.88%)  3/34 (8.82%)  0/1 (0.00%)  1/4 (25.00%) 
Upper respiratory tract infection  1  1/17 (5.88%)  1/34 (2.94%)  0/1 (0.00%)  0/4 (0.00%) 
Urinary tract infection  1  1/17 (5.88%)  1/34 (2.94%)  0/1 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Ligament sprain  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Investigations         
Weight increased  1  0/17 (0.00%)  2/34 (5.88%)  0/1 (0.00%)  0/4 (0.00%) 
Creatinine renal decreased  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Gout  1  0/17 (0.00%)  2/34 (5.88%)  0/1 (0.00%)  0/4 (0.00%) 
Hyperuricaemia  1  3/17 (17.65%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/17 (11.76%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Nervous system disorders         
Dizziness  1  0/17 (0.00%)  3/34 (8.82%)  0/1 (0.00%)  1/4 (25.00%) 
Headache  1  0/17 (0.00%)  2/34 (5.88%)  0/1 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Skin lesion  1  1/17 (5.88%)  0/34 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02496884    
Other Study ID Numbers: DS5565-A-U307
2014-003972-21 ( EudraCT Number )
First Submitted: July 8, 2015
First Posted: July 14, 2015
Results First Submitted: September 16, 2020
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020