Diabetic Neuropathy
Conditions
Keywords
Diabetic neuropathy, Ultracet, Tramadol hydrochloride, Acetaminophen, Gabapentin
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.
Interventions
DRUGTramadol hydrochloride/ Acetaminophen
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.
DRUGGabapentin
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.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Intensity Score at Day 43 | Baseline and 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Assessment of Study Medication by Investigator | Day 43 | 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 | Baseline and 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. |
| Percentage of Participants With Pain Relief | Day 15, Day 29 and Day 43 | 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 | Day 43 | 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. |
| Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline and 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| 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. | 76 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 11 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Tramadol Hydrochloride/ Acetaminophen | Gabapentin | Total |
|---|---|---|---|
| Age Continuous | 58.2 Years STANDARD_DEVIATION 7.4 | 56.6 Years STANDARD_DEVIATION 9.3 | 57.4 Years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 34 Participants | 45 Participants | 79 Participants |
| Sex: Female, Male Male | 37 Participants | 31 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 76 | 18 / 80 |
| serious Total, serious adverse events | 0 / 76 | 0 / 80 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | Change From Baseline in Pain Intensity Score at Day 43 | Baseline | 6.65 Units on a scale | Standard Deviation 1.6 |
| Tramadol Hydrochloride/ Acetaminophen | Change From Baseline in Pain Intensity Score at Day 43 | Change at Day 43 | 3.15 Units on a scale | Standard Deviation 1.83 |
| Gabapentin | Change From Baseline in Pain Intensity Score at Day 43 | Baseline | 6.30 Units on a scale | Standard Deviation 1.58 |
| Gabapentin | Change From Baseline in Pain Intensity Score at Day 43 | Change at Day 43 | 2.76 Units on a scale | Standard Deviation 1.97 |
p-value: 0.214395% CI: [-0.23, 1.01]t-test, 2 sided
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Gabapentin | Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43 | Change at Day 43:Pain interference score(n=63, 68) | -8.8 Units on a scale | Standard Deviation 14.7 |
| Gabapentin | Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43 | Baseline: Pain severity score (n=68, 73) | 4.9 Units on a scale | Standard Deviation 1.8 |
| Gabapentin | Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43 | Baseline: Pain interference score (n=71, 76) | 29.8 Units on a scale | Standard Deviation 14.8 |
| Gabapentin | 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 1.9 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Tramadol Hydrochloride/ Acetaminophen | 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 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Day 43: Emotional well being (n=63, 68) | 7.0 Units on a scale | Standard Deviation 16 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Phiysical functioning (n=71,76) | 60.6 Units on a scale | Standard Deviation 24.5 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Emotional role limitation (n=71,76) | 50.4 Units on a scale | Standard Deviation 45.7 |
| Gabapentin | 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 19.4 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Dya 43: Social functioning (n=63, 68) | 5.5 Units on a scale | Standard Deviation 24.9 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Physical role limitation (n=71,76) | 49.3 Units on a scale | Standard Deviation 41.6 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Day43:Emotional role limitation(n=63,68) | 18.1 Units on a scale | Standard Deviation 47.3 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Day 43:Physical role limitation(n=62,68) | 10.7 Units on a scale | Standard Deviation 43.3 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Emotional well-being (n=71,76) | 61.4 Units on a scale | Standard Deviation 18.9 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Pain (n=71,76) | 50.8 Units on a scale | Standard Deviation 18.1 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Energy/Fatigue (n=71,76) | 42.6 Units on a scale | Standard Deviation 19.7 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Day 43: Pain (n=63, 68) | 10.4 Units on a scale | Standard Deviation 22.2 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: Social functioning (n=71,76) | 72.2 Units on a scale | Standard Deviation 24.5 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Baseline: General health (n=71,76) | 40.3 Units on a scale | Standard Deviation 17.8 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Day 43: Energy/Fatigue (n=63, 68) | 10.0 Units on a scale | Standard Deviation 17.8 |
| Gabapentin | Change From Baseline in Short Form-36 (SF-36) Score at Day 43 | Change at Day 43: General health (n=63, 68) | 4.4 Units on a scale | Standard Deviation 14.1 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Investigator | Bad | 0 Percentage of participants |
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Investigator | No change | 31.3 Percentage of participants |
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Investigator | Very good | 17.9 Percentage of participants |
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Investigator | Good | 50.8 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Investigator | Very good | 15.3 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Investigator | Bad | 2.8 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Investigator | No change | 30.6 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Investigator | Good | 51.4 Percentage of participants |
p-value: 0.569Chi-squared
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Participants | Bad | 4.5 Percentage of participants |
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Participants | No change | 29.9 Percentage of participants |
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Participants | Good | 50.8 Percentage of participants |
| Tramadol Hydrochloride/ Acetaminophen | Overall Assessment of Study Medication by Participants | Very good | 14.9 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Participants | Very good | 16.7 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Participants | Bad | 12.5 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Participants | Good | 41.7 Percentage of participants |
| Gabapentin | Overall Assessment of Study Medication by Participants | No change | 29.2 Percentage of participants |
p-value: 0.3504Chi-squared
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 29: Became worse | 4.2 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 15: Completely resolved | 1.4 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 15: Became worse | 1.4 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 15: No change | 12.7 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 15: Relieved a little | 31.0 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 15: Relieved moderately | 26.8 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 15: Relieved a lot | 26.8 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 29: No change | 9.9 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 29: Relieved a little | 25.4 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 29: Relieved moderately | 21.1 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 29: Relieved a lot | 38.0 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 29: Completely resolved | 1.4 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 43: Became worse | 2.8 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 43: No change | 7.0 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 43: Relieved a little | 22.5 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 43: Relieved moderately | 19.7 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 43: Relieved a lot | 46.5 Percentage of Participants |
| Tramadol Hydrochloride/ Acetaminophen | Percentage of Participants With Pain Relief | Day 43: Completely resolved | 1.4 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 43: No change | 11.8 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 29: Relieved moderately | 14.5 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 43: Completely resolved | 4.0 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 15: Became worse | 4.0 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 29: Relieved a lot | 44.7 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 15: No change | 14.5 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 15: Completely resolved | 0.0 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 43: Relieved a little | 25.0 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 15: Relieved a little | 34.2 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 29: Completely resolved | 0.0 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 15: Relieved moderately | 21.1 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 43: Relieved a lot | 42.1 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 15: Relieved a lot | 26.3 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 29: Became worse | 1.3 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 43: Became worse | 1.3 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 29: No change | 10.5 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 43: Relieved moderately | 15.8 Percentage of Participants |
| Gabapentin | Percentage of Participants With Pain Relief | Day 29: Relieved a little | 29.0 Percentage of Participants |
p-value: 0.7539Chi-squared
p-value: 0.5905Chi-squared
p-value: 0.7407Chi-squared