A Phase 4 interventional study of Tramadol hydrochloride/ Acetaminophen and Gabapentin in Diabetic Neuropathy, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Janssen Korea, Ltd., Korea · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and safety of tramadol hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain.
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center and randomized (study drug is assigned by chance) study to compare the effectiveness and safety of tramadol HCl 37.5 mg/acetaminophen 325 mg with gabapentin in participants with diabetic neuropathy. The study will consist of 4 periods: Screening period (up to Day -14), Randomization period (Day 1), Dosage adjustment period (Day 15) and Maintenance period (Day 43). The participants will be randomly assigned to 1 of the 2 treatment groups: tramadol HCl 37.5 mg/acetaminophen 325 mg or gabapentin. Tramadol Hcl/acetaminophen group will receive 1 tablet for 3 days, then 1 tablet twice daily for 4 days followed by 1 tablet thrice daily for next 7 days. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Day 15 to 28, and then the increased dosage will be maintained for Day 29 to 42. Gabapentin group will receive 300 mg on Day 1, 300 mg twice daily on Day 2, and 300 mg thrice daily for Day 3 to 7. Then for Day 8 to 14, participants will receive 300 mg in the morning, 300 mg in the midday and 600 mg in the evening. If there is no pain relief, gabapentin can be increased up to 3600 mg per day for Day 15 to 28, and then the increased dosage will be maintained for Day 29 to 42. Primarily, efficacy will be evaluated by pain intensity using numeric rating scale (NRS). Participants' safety will be monitored throughout the study.
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Exclusion Criteria:
Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3, 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
Drug: Tramadol hydrochloride/ Acetaminophen
Participants will receive 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 will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
Drug: Gabapentin
Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
Also known as: Ultracet
Participants will receive 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 will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
Change From Baseline in Pain Intensity Score at Day 43
Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
Time frame: Baseline and Day 43
Percentage of Participants With Pain Relief
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.
Time frame: Day 15, Day 29 and Day 43
Overall Assessment of Study Medication by Participants
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.
Time frame: Day 43
Overall Assessment of Study Medication by Investigator
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.
Time frame: Day 43
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
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.
Time frame: Baseline and Day 43
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
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.
Time frame: Baseline and Day 43
| Milestone | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Started | 78 | 84 |
| Treated | 76 | 80 |
| Completed | 59 | 63 |
| Not completed | 19 | 21 |
| Withdrew: Other | 1 | 2 |
| Withdrew: Protocol violation | 3 | 3 |
| Withdrew: Adverse event | 11 | 11 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
| Units on a scale | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Baseline | 6.65 ± 1.60 | 6.30 ± 1.58 |
| Change at Day 43 | 3.15 ± 1.83 | 2.76 ± 1.97 |
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.
| Percentage of Participants | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Day 15: Became worse | 1.4 | 4.0 |
| Day 15: No change | 12.7 | 14.5 |
| Day 15: Relieved a little | 31.0 | 34.2 |
| Day 15: Relieved moderately | 26.8 | 21.1 |
| Day 15: Relieved a lot | 26.8 | 26.3 |
| Day 15: Completely resolved | 1.4 | 0.0 |
| Day 29: Became worse | 4.2 | 1.3 |
| Day 29: No change | 9.9 | 10.5 |
| Day 29: Relieved a little | 25.4 | 29.0 |
| Day 29: Relieved moderately | 21.1 | 14.5 |
| Day 29: Relieved a lot | 38.0 | 44.7 |
| Day 29: Completely resolved | 1.4 | 0.0 |
| Day 43: Became worse | 2.8 | 1.3 |
| Day 43: No change | 7.0 | 11.8 |
| Day 43: Relieved a little | 22.5 | 25.0 |
| Day 43: Relieved moderately | 19.7 | 15.8 |
| Day 43: Relieved a lot | 46.5 | 42.1 |
| Day 43: Completely resolved | 1.4 | 4.0 |
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.
| Percentage of participants | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Bad | 4.5 | 12.5 |
| No change | 29.9 | 29.2 |
| Good | 50.8 | 41.7 |
| Very good | 14.9 | 16.7 |
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.
| Percentage of participants | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Bad | 0 | 2.8 |
| No change | 31.3 | 30.6 |
| Good | 50.8 | 51.4 |
| Very good | 17.9 | 15.3 |
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.
| Units on a scale | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Baseline: Pain severity score (n=68, 73) | 4.5 ± 1.3 | 4.9 ± 1.8 |
| Change at Day 43: Pain severity score (n=60, 60) | 0.1 ± 2.3 | 0.1 ± 1.9 |
| Baseline: Pain interference score (n=71, 76) | 30.2 ± 14.8 | 29.8 ± 14.8 |
| Change at Day 43:Pain interference score(n=63, 68) | -11.0 ± 15.4 | -8.8 ± 14.7 |
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.
| Units on a scale | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| Baseline: Phiysical functioning (n=71,76) | 56.3 ± 24.1 | 60.6 ± 24.5 |
| Change at Day 43: Physical functioning (n=63, 68)) | 3.2 ± 19.7 | 3.2 ± 19.4 |
| Baseline: Physical role limitation (n=71,76) | 42.3 ± 42.8 | 49.3 ± 41.6 |
| Change at Day 43:Physical role limitation(n=62,68) | 13.7 ± 41.4 | 10.7 ± 43.3 |
| Baseline: Pain (n=71,76) | 49.3 ± 20.9 | 50.8 ± 18.1 |
| Change at Day 43: Pain (n=63, 68) | 15.6 ± 22.7 | 10.4 ± 22.2 |
| Baseline: General health (n=71,76) | 38.0 ± 20.4 | 40.3 ± 17.8 |
| Change at Day 43: General health (n=63, 68) | 4.6 ± 18.8 | 4.4 ± 14.1 |
| Baseline: Emotional role limitation (n=71,76) | 46.9 ± 44.9 | 50.4 ± 45.7 |
| Change at Day43:Emotional role limitation(n=63,68) | 12.7 ± 49.9 | 18.1 ± 47.3 |
| Baseline: Energy/Fatigue (n=71,76) | 39.4 ± 22.1 | 42.6 ± 19.7 |
| Change at Day 43: Energy/Fatigue (n=63, 68) | 5.7 ± 21.8 | 10.0 ± 17.8 |
| Baseline: Emotional well-being (n=71,76) | 57.2 ± 22.0 | 61.4 ± 18.9 |
| Change at Day 43: Emotional well being (n=63, 68) | 5.3 ± 23.3 | 7.0 ± 16.0 |
| Baseline: Social functioning (n=71,76) | 68.3 ± 23.3 | 72.2 ± 24.5 |
| Change at Dya 43: Social functioning (n=63, 68) | 9.9 ± 24.9 | 5.5 ± 24.9 |
Collected over Baseline up to Day 43. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | — | 0/76 (0%) | 33/76 (43.4%) |
| Gabapentin | — | 0/80 (0%) | 18/80 (22.5%) |
| Event | Tramadol Hydrochloride/ Acetaminophen | Gabapentin |
|---|---|---|
| NauseaGastrointestinal disorders | 14/76 | 4/80 |
| DizzinessNervous system disorders | 13/76 | 10/80 |
| HeadacheNervous system disorders | 6/76 | 4/80 |
| DyspepsiaGastrointestinal disorders | 6/76 | 3/80 |
| SomnolenceNervous system disorders | 5/76 | 5/80 |
Full analysis set (FAS) included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data.
| Age Continuous(Years) | Tramadol Hydrochloride/ Acetaminophen | Gabapentin | Total |
|---|---|---|---|
| Mean | 58.2 ± 7.4 | 56.6 ± 9.3 | 57.4 ± 8.4 |
| Sex: Female, Male(Participants) | Tramadol Hydrochloride/ Acetaminophen | Gabapentin | Total |
|---|---|---|---|
| Female | 34 | 45 | 79 |
| Male | 37 | 31 | 68 |
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Janssen Korea, Ltd., Korea