Back to resultsA Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tramadol hydrochloride/ Acetaminophen
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Diabetic neuropathy, Ultracet, Tramadol hydrochloride, Acetaminophen, Gabapentin
Eligibility Criteria
Inclusion Criteria:
- Participants having painful symmetric neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) in the lower limbs applicable to both of the following conditions: decreased sensation of leg to monofilament, none or decreased ankle reflexes or decreased vibratory sensation and pain symptoms such as numbness (loss of sensation), tingling, paresthesia (a skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause), burning, shooting pain, stabbing or lancinating (characterized by a sensation of cutting, piercing, or stabbing) pain
- Participants having painful diabetic neuropathy in the lower limbs for 3 months before randomization
- Participants diagnosed with Type ll diabetes and stable blood sugar level controlled with an oral medication, insulin or diet therapy for 3 months before randomization
- Participants with glycated hemoglobin (HbA1c) less than or equal to 10 percent
- Participants with pain intensity score of greater than or equal to 4 on numeric rating scale (NRS) for the last 48 hours
Exclusion Criteria:
- Participants who have previously experienced failure of tramadol treatment or have discontinued tramadol administration due to adverse event
- Participants who have received the prohibited medication before randomization (e.g., capsaicin, use of systemic steroids, steroid or local anesthetic injections, tramadol HCl or tramadol combination, gabapentin, opioid analgesics, antidepressants, anticonvulsants, alpha-lipoic acid, acupuncture, COX-2 selective inhibitors, long-acting NSAIDs, opioid analgesics, sedative-hypnotics, muscle relaxants, anxiolytics, antipsychotics, TENS, short-acting non-opioid analgesics)
- Participants with neuropathic pain caused by other reasons (e.g., alcohol abuse, connective tissue disease, toxic exposure, infection, neoplasm, ischemia)
- Participants suffering from painful diabetic neuropathy over 10 years
- Participants with physical damage or disease which may cause abnormal absorption, excessive accumulation, metabolism or excretion disorder of the study medication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tramadol hydrochloride (HCl)/ Acetaminophen
Gabapentin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00634543
First Posted
March 6, 2008
Last Updated
July 26, 2013
Sponsor
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT00634543
Brief Title
A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
Official Title
Comparison of the Effectiveness and Safety Between Tramadol 37.5 Mg/Acetaminophen 325mg And Gabapentin for The Treatment of Painful Diabetic Neuropathy: Multicenter, Randomized, Open Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Korea, Ltd., Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Diabetic neuropathy, Ultracet, Tramadol hydrochloride, Acetaminophen, Gabapentin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tramadol hydrochloride (HCl)/ Acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tramadol hydrochloride/ Acetaminophen
Other Intervention Name(s)
Ultracet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Pain Intensity Score at Day 43
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With Pain Relief
Description
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
Title
Overall Assessment of Study Medication by Participants
Description
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
Title
Overall Assessment of Study Medication by Investigator
Description
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
Title
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Description
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
Title
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants having painful symmetric neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) in the lower limbs applicable to both of the following conditions: decreased sensation of leg to monofilament, none or decreased ankle reflexes or decreased vibratory sensation and pain symptoms such as numbness (loss of sensation), tingling, paresthesia (a skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause), burning, shooting pain, stabbing or lancinating (characterized by a sensation of cutting, piercing, or stabbing) pain
Participants having painful diabetic neuropathy in the lower limbs for 3 months before randomization
Participants diagnosed with Type ll diabetes and stable blood sugar level controlled with an oral medication, insulin or diet therapy for 3 months before randomization
Participants with glycated hemoglobin (HbA1c) less than or equal to 10 percent
Participants with pain intensity score of greater than or equal to 4 on numeric rating scale (NRS) for the last 48 hours
Exclusion Criteria:
Participants who have previously experienced failure of tramadol treatment or have discontinued tramadol administration due to adverse event
Participants who have received the prohibited medication before randomization (e.g., capsaicin, use of systemic steroids, steroid or local anesthetic injections, tramadol HCl or tramadol combination, gabapentin, opioid analgesics, antidepressants, anticonvulsants, alpha-lipoic acid, acupuncture, COX-2 selective inhibitors, long-acting NSAIDs, opioid analgesics, sedative-hypnotics, muscle relaxants, anxiolytics, antipsychotics, TENS, short-acting non-opioid analgesics)
Participants with neuropathic pain caused by other reasons (e.g., alcohol abuse, connective tissue disease, toxic exposure, infection, neoplasm, ischemia)
Participants suffering from painful diabetic neuropathy over 10 years
Participants with physical damage or disease which may cause abnormal absorption, excessive accumulation, metabolism or excretion disorder of the study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Korea, Ltd. Clinical Trial
Organizational Affiliation
Janssen Korea, Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
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