A Study of TAS-205 for Duchenne Muscular Dystrophy
Sponsor
Taiho Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02246478
Collaborator
(none)
23
1
4
12
1.9
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3500 lives male births. DMD patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and loss of upper body function. The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 after single and multiple doses in DMD patients. It is also evaluated if TAS-205 affects the urinary excretion of pharmacodynamic (PD) marker in DMD patients.
Study Design
Study Type:
Interventional
Actual Enrollment
:
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Single and Multiple Doses of TAS-205 in Patients With Duchenne Muscular Dystrophy
Study Start Date
:
Sep 1, 2014
Actual Primary Completion Date
:
Jun 1, 2015
Actual Study Completion Date
:
Sep 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo
Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
|
| Active Comparator: TAS-205 low dose
|
Drug: TAS-205
Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
|
| Active Comparator: TAS-205 middle dose
|
Drug: TAS-205
Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
|
| Active Comparator: TAS-205 high dose
|
Drug: TAS-205
Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events [From the first administration day to the end of the observation period (ie. single-dose phase: 8 days, multiple-doses phase: 14 days)]
Source Vocabulary Name for Table Default: CTCAE (4.03)
Secondary Outcome Measures
- Peak Plasma Concentration (Cmax) of TAS-205 [Single-dose phase: immediately before dosing, 0, 0.5, 1, 2, 4, 8, 24, 48 hours post-dose, Multiple-dose phase: Days 1 and 7, immediately before morning dose, 0.5, 1, 2, 4, and 8 hours post-dose and Day 4, immediately before morning dose.]
Due to inspection missing, some data were not analyzed.
- Area Under the Plasma Concentration Versus Time Curve (AUC) of TAS-205 [Administration period (ie. single-dose phase: from single administration day to 48 hours after the administration, multiple-dose phase: from the first administration day to 8 hours after the last administration)]
Due to inspection missing, some data were not analyzed.
- The Urinary Excretion of PD Marker [Single-dose: Day -1 before administration, 0-24 hr post-dose, and 24-48 hr post-dose, Multiple-doses: Day -1 before administration, 0 hr after administration on Day 1 and 4 to the following day (Day 2 and 5), and 0-24 hr after administration on Day 7.]
Ratio of prostaglandin E2 metabolite / creatinine Due to inspection missing, some data were not analyzed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 15 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Able to give an informed consent. If applicable, able to give an informed assent.
-
Male and >= 5 years and < 16 years of age.
-
Bodyweight of >= 15.0 kg and < 75.0 kg.
-
Phenotypic evidence of DMD.
-
Able to take tablets.
-
If taking oral glucocorticosteroids no significant change in total daily dosage or dosing regimen after enrollment.
-
Confirmed the urinary PD marker over its criteria.
-
Able to follow the study protocol.
Exclusion Criteria:
-
Current diagnosis or history of any drug allergy.
-
A forced vital capacity (FVC) < 50% of predicted value.
-
A left ventricular ejection fraction (EF) < 50% or fractional shortening (FS) < 25% based on echocardiogram (ECHO).
-
Ongoing immunosuppressive therapy (other than corticosteroids).
-
With severe disease such as hepatic disease, kidney disease and others.
-
With any systemic allergic disease or any chronic inflammatory disease.
-
Treated with any other investigational agents within 90 days.
-
Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Center of Neurology and Psychiatry | Tokyo | Japan | 187-8551 |
Sponsors and Collaborators
- Taiho Pharmaceutical Co., Ltd.
Investigators
- Study Director: Taiho Pharmaceutical Co.,Ltd., Taiho Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02246478
Other Study ID Numbers:
- Taiho10053030
First Posted:
Sep 22, 2014
Last Update Posted:
Jun 4, 2021
Last Verified:
May 1, 2021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Two participants in 21 participants of Single-dose phase discontinued after Single-dose phase. So, 19 participants moved to Multiple-dose phase. And new two participants enrolled in Multiple-dose phase. |
| Arm/Group Title | Placebo | TAS-205 Low Dose | TAS-205 Middle Dose | TAS-205 High Dose |
|---|---|---|---|---|
| Arm/Group Description | Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals |
| Period Title: Single-dose Phase | ||||
| STARTED | 6 | 5 | 5 | 5 |
| COMPLETED | 6 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Single-dose Phase | ||||
| STARTED | 6 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 4 |
| NOT COMPLETED | 1 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo | TAS-205 Low Dose | TAS-205 Middle Dose | TAS-205 High Dose | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | Total of all reporting groups |
| Overall Participants | 6 | 6 | 5 | 6 | 23 |
| Age (Count of Participants) | |||||
| <=18 years |
6
100%
|
6
100%
|
5
100%
|
6
100%
|
23
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
6
100%
|
6
100%
|
5
100%
|
6
100%
|
23
100%
|
| Region of Enrollment (participants) [Number] | |||||
| Japan |
6
100%
|
6
100%
|
5
100%
|
6
100%
|
23
100%
|
Outcome Measures
| Title | Incidence of Adverse Events |
|---|---|
| Description | Source Vocabulary Name for Table Default: CTCAE (4.03) |
| Time Frame | From the first administration day to the end of the observation period (ie. single-dose phase: 8 days, multiple-doses phase: 14 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| About repeated-dose period, one participants of placebo group and one of TAS-205 high dose group were excluded from analysis population, due to significant deviation from the protocol. |
| Arm/Group Title | Placebo | TAS-205 Low Dose | TAS-205 Middle Dose | TAS-205 High Dose |
|---|---|---|---|---|
| Arm/Group Description | Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals |
| Measure Participants | 6 | 6 | 5 | 6 |
| Single-dose Period |
0
0%
|
3
50%
|
1
20%
|
1
16.7%
|
| Repeated-dose Period |
0
0%
|
1
16.7%
|
3
60%
|
1
16.7%
|
| Title | Peak Plasma Concentration (Cmax) of TAS-205 |
|---|---|
| Description | Due to inspection missing, some data were not analyzed. |
| Time Frame | Single-dose phase: immediately before dosing, 0, 0.5, 1, 2, 4, 8, 24, 48 hours post-dose, Multiple-dose phase: Days 1 and 7, immediately before morning dose, 0.5, 1, 2, 4, and 8 hours post-dose and Day 4, immediately before morning dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| About repeated-dose period, one participants of TAS-205 high dose group was excluded from analysis population, due to significant deviation from the protocol. |
| Arm/Group Title | TAS-205 Low Dose | TAS-205 Middle Dose | TAS-205 High Dose |
|---|---|---|---|
| Arm/Group Description | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals |
| Measure Participants | 5 | 5 | 5 |
| Single-dose Period |
839
(383)
|
1847
(996)
|
3202
(1493)
|
| Repeated-dose Period (Day 1) |
1004
(656)
|
1894
(691)
|
2635
(2813)
|
| Repeated-dose Period (Day 7) |
891
(297)
|
2322
(776)
|
4660
(3671)
|
| Title | Area Under the Plasma Concentration Versus Time Curve (AUC) of TAS-205 |
|---|---|
| Description | Due to inspection missing, some data were not analyzed. |
| Time Frame | Administration period (ie. single-dose phase: from single administration day to 48 hours after the administration, multiple-dose phase: from the first administration day to 8 hours after the last administration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| About repeated-dose period, one paticipant of TAS-205 high dose group was excluded from analysis population, due to significant deviation from the protocol. |
| Arm/Group Title | TAS-205 Low Dose | TAS-205 Middle Dose | TAS-205 High Dose |
|---|---|---|---|
| Arm/Group Description | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals |
| Measure Participants | 5 | 5 | 5 |
| Single-dose Period |
2604
(851)
|
5776
(2951)
|
9118
(3334)
|
| Repeated-dose Period (Day 1) |
2525
(1208)
|
5281
(2553)
|
6391
(4731)
|
| Repeated-dose Period (Day 7) |
2642
(673)
|
6087
(2561)
|
9452
(4405)
|
| Title | The Urinary Excretion of PD Marker |
|---|---|
| Description | Ratio of prostaglandin E2 metabolite / creatinine Due to inspection missing, some data were not analyzed. |
| Time Frame | Single-dose: Day -1 before administration, 0-24 hr post-dose, and 24-48 hr post-dose, Multiple-doses: Day -1 before administration, 0 hr after administration on Day 1 and 4 to the following day (Day 2 and 5), and 0-24 hr after administration on Day 7. |
Outcome Measure Data
| Analysis Population Description |
|---|
| About repeated-dose period, one participants of placebo group and one of TAS-205 high dose group were excluded from analysis population, due to significant deviation from the protocol. |
| Arm/Group Title | Placebo | TAS-205 Low Dose | TAS-205 Middle Dose | TAS-205 High Dose |
|---|---|---|---|---|
| Arm/Group Description | Placebo: ・Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | TAS-205: ・Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals ・Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals |
| Measure Participants | 6 | 5 | 5 | 5 |
| Single-dose Period |
1.05
(0.14)
|
0.92
(0.28)
|
1.13
(0.31)
|
1.26
(0.46)
|
| Repeated-dose Period (Day 1) |
1.22
(0.34)
|
1.23
(0.33)
|
1.07
(0.26)
|
1.26
(0.34)
|
| Repeated-dose Period (Day 7) |
1.22
(0.46)
|
1.27
(0.35)
|
1.27
(0.21)
|
0.76
(0.17)
|
Adverse Events
| Time Frame | From the first administration day to the end of the observation period (ie. single-dose phase: 8 days, multiple-doses phase: 14 days) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Events were formed by participants of single-dose period and multiple-dose period. | |||||||||||||||
| Arm/Group Title | Placebo, Single-dose Phase | TAS-205 Low Dose, Single-dose Phase | TAS-205 Middle Dose, Single-dose Phase | TAS-205 High Dose, Single-dose | Placebo, Multiple-dose Phase | TAS-205 Low Dose, Multiple-dose Phase | TAS-205 Middle Dose, Multiple-dose Phase | TAS-205 High Dose, Multiple-dose Phase | ||||||||
| Arm/Group Description | Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals | Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals | Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals | Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals | Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals | ||||||||
All Cause Mortality |
||||||||||||||||
| Placebo, Single-dose Phase | TAS-205 Low Dose, Single-dose Phase | TAS-205 Middle Dose, Single-dose Phase | TAS-205 High Dose, Single-dose | Placebo, Multiple-dose Phase | TAS-205 Low Dose, Multiple-dose Phase | TAS-205 Middle Dose, Multiple-dose Phase | TAS-205 High Dose, Multiple-dose Phase | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/4 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Placebo, Single-dose Phase | TAS-205 Low Dose, Single-dose Phase | TAS-205 Middle Dose, Single-dose Phase | TAS-205 High Dose, Single-dose | Placebo, Multiple-dose Phase | TAS-205 Low Dose, Multiple-dose Phase | TAS-205 Middle Dose, Multiple-dose Phase | TAS-205 High Dose, Multiple-dose Phase | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/4 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Placebo, Single-dose Phase | TAS-205 Low Dose, Single-dose Phase | TAS-205 Middle Dose, Single-dose Phase | TAS-205 High Dose, Single-dose | Placebo, Multiple-dose Phase | TAS-205 Low Dose, Multiple-dose Phase | TAS-205 Middle Dose, Multiple-dose Phase | TAS-205 High Dose, Multiple-dose Phase | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 3/5 (60%) | 1/5 (20%) | 1/5 (20%) | 0/5 (0%) | 1/5 (20%) | 3/5 (60%) | 1/4 (25%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| General disorders | ||||||||||||||||
| Catheter site pain | 0/6 (0%) | 0 | 2/5 (40%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Nasopharyngitis | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Arthropod sting | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Ligament sprain | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Investigations | ||||||||||||||||
| Blood bilirubin increased | 0/6 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Cystatin C increased | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||
| Hyperuricemia | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Epistaxis | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Erythema | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Nail bed bleeding | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Taiho Pharmaceutical Co., Ltd. |
|---|---|
| Organization | Clinical Trial Registration Contact |
| Phone | |
| toiawase@taiho.co.jp |
Responsible Party:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02246478
Other Study ID Numbers:
- Taiho10053030
First Posted:
Sep 22, 2014
Last Update Posted:
Jun 4, 2021
Last Verified:
May 1, 2021