Trial Outcomes & Findings for A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy (NCT NCT00634543)
NCT ID: NCT00634543
Last Updated: 2013-08-12
Results Overview
Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
Baseline and Day 43
Results posted on
2013-08-12
Participant Flow
Participant milestones
| Measure |
Tramadol Hydrochloride/ Acetaminophen
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
84
|
|
Overall Study
Treated
|
76
|
80
|
|
Overall Study
COMPLETED
|
59
|
63
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
Reasons for withdrawal
| Measure |
Tramadol Hydrochloride/ Acetaminophen
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Overall Study
Other
|
1
|
2
|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Adverse Event
|
11
|
11
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=71 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=76 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.2 Years
STANDARD_DEVIATION 7.4 • n=93 Participants
|
56.6 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
57.4 Years
STANDARD_DEVIATION 8.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 43Population: Full analysis set (FAS) included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.
Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
Outcome measures
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=71 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=76 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Change From Baseline in Pain Intensity Score at Day 43
Baseline
|
6.65 Units on a scale
Standard Deviation 1.60
|
6.30 Units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Pain Intensity Score at Day 43
Change at Day 43
|
3.15 Units on a scale
Standard Deviation 1.83
|
2.76 Units on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Day 15, Day 29 and Day 43Population: FAS included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.
Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved.
Outcome measures
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=71 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=76 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Percentage of Participants With Pain Relief
Day 15: Became worse
|
1.4 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 15: No change
|
12.7 Percentage of Participants
|
14.5 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 15: Relieved a little
|
31.0 Percentage of Participants
|
34.2 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 15: Relieved moderately
|
26.8 Percentage of Participants
|
21.1 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 15: Relieved a lot
|
26.8 Percentage of Participants
|
26.3 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 15: Completely resolved
|
1.4 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 29: Became worse
|
4.2 Percentage of Participants
|
1.3 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 29: No change
|
9.9 Percentage of Participants
|
10.5 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 29: Relieved a little
|
25.4 Percentage of Participants
|
29.0 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 29: Relieved moderately
|
21.1 Percentage of Participants
|
14.5 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 29: Relieved a lot
|
38.0 Percentage of Participants
|
44.7 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 29: Completely resolved
|
1.4 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 43: Became worse
|
2.8 Percentage of Participants
|
1.3 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 43: No change
|
7.0 Percentage of Participants
|
11.8 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 43: Relieved a little
|
22.5 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 43: Relieved moderately
|
19.7 Percentage of Participants
|
15.8 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 43: Relieved a lot
|
46.5 Percentage of Participants
|
42.1 Percentage of Participants
|
|
Percentage of Participants With Pain Relief
Day 43: Completely resolved
|
1.4 Percentage of Participants
|
4.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 43Population: FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'N' signifies number of participants who were evaluated for this outcome measure.
Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.
Outcome measures
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=67 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=72 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Overall Assessment of Study Medication by Participants
Bad
|
4.5 Percentage of participants
|
12.5 Percentage of participants
|
|
Overall Assessment of Study Medication by Participants
No change
|
29.9 Percentage of participants
|
29.2 Percentage of participants
|
|
Overall Assessment of Study Medication by Participants
Good
|
50.8 Percentage of participants
|
41.7 Percentage of participants
|
|
Overall Assessment of Study Medication by Participants
Very good
|
14.9 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 43Population: FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'N' signifies number of participants who were evaluated for this outcome measure.
Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.
Outcome measures
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=67 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=72 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Overall Assessment of Study Medication by Investigator
Bad
|
0 Percentage of participants
|
2.8 Percentage of participants
|
|
Overall Assessment of Study Medication by Investigator
No change
|
31.3 Percentage of participants
|
30.6 Percentage of participants
|
|
Overall Assessment of Study Medication by Investigator
Good
|
50.8 Percentage of participants
|
51.4 Percentage of participants
|
|
Overall Assessment of Study Medication by Investigator
Very good
|
17.9 Percentage of participants
|
15.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for this outcome measure at a particular time point.
The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely.
Outcome measures
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=71 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=76 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Baseline: Pain severity score (n=68, 73)
|
4.5 Units on a scale
Standard Deviation 1.3
|
4.9 Units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Change at Day 43: Pain severity score (n=60, 60)
|
0.1 Units on a scale
Standard Deviation 2.3
|
0.1 Units on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Baseline: Pain interference score (n=71, 76)
|
30.2 Units on a scale
Standard Deviation 14.8
|
29.8 Units on a scale
Standard Deviation 14.8
|
|
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Change at Day 43:Pain interference score(n=63, 68)
|
-11.0 Units on a scale
Standard Deviation 15.4
|
-8.8 Units on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline and Day 43Population: FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for at given time point.
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
Outcome measures
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=71 Participants
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=76 Participants
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day 43: Physical functioning (n=63, 68))
|
3.2 Units on a scale
Standard Deviation 19.7
|
3.2 Units on a scale
Standard Deviation 19.4
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Physical role limitation (n=71,76)
|
42.3 Units on a scale
Standard Deviation 42.8
|
49.3 Units on a scale
Standard Deviation 41.6
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day 43:Physical role limitation(n=62,68)
|
13.7 Units on a scale
Standard Deviation 41.4
|
10.7 Units on a scale
Standard Deviation 43.3
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Pain (n=71,76)
|
49.3 Units on a scale
Standard Deviation 20.9
|
50.8 Units on a scale
Standard Deviation 18.1
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day 43: Pain (n=63, 68)
|
15.6 Units on a scale
Standard Deviation 22.7
|
10.4 Units on a scale
Standard Deviation 22.2
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: General health (n=71,76)
|
38.0 Units on a scale
Standard Deviation 20.4
|
40.3 Units on a scale
Standard Deviation 17.8
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day 43: General health (n=63, 68)
|
4.6 Units on a scale
Standard Deviation 18.8
|
4.4 Units on a scale
Standard Deviation 14.1
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Emotional role limitation (n=71,76)
|
46.9 Units on a scale
Standard Deviation 44.9
|
50.4 Units on a scale
Standard Deviation 45.7
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day43:Emotional role limitation(n=63,68)
|
12.7 Units on a scale
Standard Deviation 49.9
|
18.1 Units on a scale
Standard Deviation 47.3
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Energy/Fatigue (n=71,76)
|
39.4 Units on a scale
Standard Deviation 22.1
|
42.6 Units on a scale
Standard Deviation 19.7
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day 43: Energy/Fatigue (n=63, 68)
|
5.7 Units on a scale
Standard Deviation 21.8
|
10.0 Units on a scale
Standard Deviation 17.8
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Emotional well-being (n=71,76)
|
57.2 Units on a scale
Standard Deviation 22.0
|
61.4 Units on a scale
Standard Deviation 18.9
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Day 43: Emotional well being (n=63, 68)
|
5.3 Units on a scale
Standard Deviation 23.3
|
7.0 Units on a scale
Standard Deviation 16.0
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Social functioning (n=71,76)
|
68.3 Units on a scale
Standard Deviation 23.3
|
72.2 Units on a scale
Standard Deviation 24.5
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Change at Dya 43: Social functioning (n=63, 68)
|
9.9 Units on a scale
Standard Deviation 24.9
|
5.5 Units on a scale
Standard Deviation 24.9
|
|
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Baseline: Phiysical functioning (n=71,76)
|
56.3 Units on a scale
Standard Deviation 24.1
|
60.6 Units on a scale
Standard Deviation 24.5
|
Adverse Events
Tramadol Hydrochloride/ Acetaminophen
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tramadol Hydrochloride/ Acetaminophen
n=76 participants at risk
Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
Gabapentin
n=80 participants at risk
Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
17.1%
13/76 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
12.5%
10/80 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
6.6%
5/76 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
6.2%
5/80 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
7.9%
6/76 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
5.0%
4/80 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
18.4%
14/76 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
5.0%
4/80 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
6/76 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
3.8%
3/80 • Baseline up to Day 43
Safety analysis population included all randomly assigned participants who received at least 1 dose of study medication.
|
Additional Information
Clinical Research Director
Janssen Korea / 25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702 Korea
Phone: 82-2-2094-4518
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is cancelled.
- Publication restrictions are in place
Restriction type: OTHER