Trial Outcomes & Findings for An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain (NCT NCT01112267)
NCT ID: NCT01112267
Last Updated: 2013-07-24
Results Overview
The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
COMPLETED
PHASE3
248 participants
Baseline up to Day 29
2013-07-24
Participant Flow
Participant milestones
| Measure |
Tramadol HCl/Acetaminophen
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
122
|
|
Overall Study
Treated
|
125
|
120
|
|
Overall Study
COMPLETED
|
92
|
104
|
|
Overall Study
NOT COMPLETED
|
34
|
18
|
Reasons for withdrawal
| Measure |
Tramadol HCl/Acetaminophen
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Overall Study
Adverse Event
|
24
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Participants not compliant
|
1
|
2
|
|
Overall Study
Participants not receive any study drug
|
1
|
2
|
Baseline Characteristics
An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
Baseline characteristics by cohort
| Measure |
Tramadol HCl/Acetaminophen
n=125 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=120 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.93 Years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
60.39 Years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
60.16 Years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 29Population: Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=85 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=90 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Percentage of Participants With Reduction in Pain Intensity
|
57.65 Percentage of Participants
Interval 47.14 to 68.15
|
41.11 Percentage of Participants
Interval 30.95 to 51.28
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=85 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=90 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Change From Baseline in Pain Intensity at Day 29
Baseline
|
6.334 Unit on a scale
Standard Deviation 1.383
|
6.000 Unit on a scale
Standard Deviation 1.331
|
|
Change From Baseline in Pain Intensity at Day 29
Change at Day 29
|
2.299 Unit on a scale
Standard Deviation 1.764
|
1.549 Unit on a scale
Standard Deviation 1.578
|
SECONDARY outcome
Timeframe: Day 8, Day 15 and Day 29Population: the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=85 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=90 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Percentage of Participants With Pain Relief
Day 8: Slight relief (n=82,88)
|
70.73 Percentage of participants
Interval 60.88 to 80.58
|
53.41 Percentage of participants
Interval 42.99 to 63.83
|
|
Percentage of Participants With Pain Relief
Day 15: Slight relief (n=85,89)
|
82.35 Percentage of participants
Interval 74.25 to 90.46
|
65.17 Percentage of participants
Interval 55.27 to 75.07
|
|
Percentage of Participants With Pain Relief
Day 29, Slight relief (85,89)
|
81.18 Percentage of participants
Interval 72.87 to 89.49
|
77.53 Percentage of participants
Interval 68.86 to 86.2
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in "Reported (Rptd.) Health Transition" domain higher score indicates worse quality of life.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=85 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=90 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Physical functioning
|
46.71 Unit on a scale
Standard Deviation 20.71
|
47.94 Unit on a scale
Standard Deviation 20.80
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Physical functioning (n=83,87)
|
9.82 Unit on a scale
Standard Deviation 18.35
|
6.67 Unit on a scale
Standard Deviation 15.99
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Role physical
|
44.93 Unit on a scale
Standard Deviation 24.18
|
49.51 Unit on a scale
Standard Deviation 26.17
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Role Physical (n=83,87)
|
16.04 Unit on a scale
Standard Deviation 23.89
|
8.69 Unit on a scale
Standard Deviation 22.62
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Bodily pain
|
34.66 Unit on a scale
Standard Deviation 14.46
|
35.99 Unit on a scale
Standard Deviation 13.89
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Bodily pain (n=83,87)
|
19.39 Unit on a scale
Standard Deviation 18.99
|
17.69 Unit on a scale
Standard Deviation 14.84
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: General health
|
43.56 Unit on a scale
Standard Deviation 17.92
|
48.11 Unit on a scale
Standard Deviation 17.05
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: General health (n=83,87)
|
7.36 Unit on a scale
Standard Deviation 14.41
|
2.77 Unit on a scale
Standard Deviation 12.58
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Vitality
|
38.82 Unit on a scale
Standard Deviation 19.93
|
42.71 Unit on a scale
Standard Deviation 17.83
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Vitality (n=83,87)
|
11.14 Unit on a scale
Standard Deviation 20.55
|
5.82 Unit on a scale
Standard Deviation 18.94
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Social functioning
|
64.26 Unit on a scale
Standard Deviation 22.59
|
64.58 Unit on a scale
Standard Deviation 26.98
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Social functioning (n=83,87)
|
11.75 Unit on a scale
Standard Deviation 25.70
|
6.61 Unit on a scale
Standard Deviation 20.60
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Role emotional
|
61.76 Unit on a scale
Standard Deviation 27.41
|
61.57 Unit on a scale
Standard Deviation 29.34
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Role emotional (n=83,87)
|
8.13 Unit on a scale
Standard Deviation 28.93
|
7.47 Unit on a scale
Standard Deviation 28.25
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Mental Health
|
61.06 Unit on a scale
Standard Deviation 19.03
|
60.56 Unit on a scale
Standard Deviation 19.34
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Mental Health (n=83,87)
|
20.48 Unit on a scale
Standard Deviation 23.20
|
18.39 Unit on a scale
Standard Deviation 24.61
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Baseline: Rptd. health transition
|
65.00 Unit on a scale
Standard Deviation 24.76
|
63.61 Unit on a scale
Standard Deviation 20.92
|
|
Change From Baseline in Short Form (SF)-36 Score at Day 29
Change at Day 29: Rptd. health transition(n=83,87)
|
-18.07 Unit on a scale
Standard Deviation 25.99
|
-6.90 Unit on a scale
Standard Deviation 30.19
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=85 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=90 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29
Baseline
|
39.626 Unit on a scale
Standard Deviation 12.239
|
38.126 Unit on a scale
Standard Deviation 13.518
|
|
Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29
Change at Day 29 (n=87,83)
|
11.216 Unit on a scale
Standard Deviation 11.856
|
7.178 Unit on a scale
Standard Deviation 13.879
|
SECONDARY outcome
Timeframe: Day 29Population: The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here 'N' signifies those participants who were evaluated for this outcome measure.
Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=80 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=83 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment on Investigational Product
|
81.25 Percentage of participants
Interval 72.7 to 89.8
|
69.88 Percentage of participants
Interval 60.01 to 79.75
|
SECONDARY outcome
Timeframe: Day 29Population: The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here 'N' signifies those participants who were evaluated for this outcome measure.
Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
Outcome measures
| Measure |
Tramadol HCl/Acetaminophen
n=80 Participants
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=83 Participants
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Percentage of Participants With Participants' Global Assessment on Investigational Product
|
76.25 Percentage of participants
Interval 66.92 to 85.58
|
72.29 Percentage of participants
Interval 62.66 to 81.92
|
Adverse Events
Tramadol HCl/Acetaminophen
Placebo
Serious adverse events
| Measure |
Tramadol HCl/Acetaminophen
n=125 participants at risk
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=120 participants at risk
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.80%
1/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
Other adverse events
| Measure |
Tramadol HCl/Acetaminophen
n=125 participants at risk
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
Placebo
n=120 participants at risk
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/125 • Baseline up to Day 29
|
2.5%
3/120 • Baseline up to Day 29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/125 • Baseline up to Day 29
|
2.5%
3/120 • Baseline up to Day 29
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
6/125 • Baseline up to Day 29
|
3.3%
4/120 • Baseline up to Day 29
|
|
Nervous system disorders
Headache
|
8.8%
11/125 • Baseline up to Day 29
|
5.0%
6/120 • Baseline up to Day 29
|
|
Nervous system disorders
Dizziness
|
27.2%
34/125 • Baseline up to Day 29
|
8.3%
10/120 • Baseline up to Day 29
|
|
Nervous system disorders
Somnolence
|
14.4%
18/125 • Baseline up to Day 29
|
3.3%
4/120 • Baseline up to Day 29
|
|
Renal and urinary disorders
Dysuria
|
3.2%
4/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
5/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Nausea
|
36.0%
45/125 • Baseline up to Day 29
|
10.0%
12/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Constipation
|
18.4%
23/125 • Baseline up to Day 29
|
3.3%
4/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
3/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Dyspepsia
|
10.4%
13/125 • Baseline up to Day 29
|
10.0%
12/120 • Baseline up to Day 29
|
|
General disorders
Thirst
|
2.4%
3/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Psychiatric disorders
Insomnia
|
4.8%
6/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.4%
18/125 • Baseline up to Day 29
|
3.3%
4/120 • Baseline up to Day 29
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.2%
4/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
3/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
3/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Skin and subcutaneous tissue disorders
Cold sweating
|
2.4%
3/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
21/125 • Baseline up to Day 29
|
4.2%
5/120 • Baseline up to Day 29
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/125 • Baseline up to Day 29
|
3.3%
4/120 • Baseline up to Day 29
|
|
General disorders
Face oedema
|
2.4%
3/125 • Baseline up to Day 29
|
0.00%
0/120 • Baseline up to Day 29
|
Additional Information
Therapeutic area Scientist
Janssen Korea/ Seoul
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot provide the any trial related information to external parties' without mutual agreement with the sponsor. This is valid even after the contract is canceled.
- Publication restrictions are in place
Restriction type: OTHER