Diabetic NeuropathyPhase 4NCT00634543
A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
A Phase 4 study testing Tramadol hydrochloride/ Acetaminophen and Gabapentin in people with Diabetic Neuropathy, run by Janssen Korea, Ltd., Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Tramadol hydrochloride/ Acetaminophen and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- Tramadol hydrochloride/ Acetaminophen, Gabapentin
- Keywords
- Diabetic neuropathy, Ultracet, Tramadol hydrochloride, Acetaminophen, Gabapentin
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochloride/ AcetaminophenDrug
Also called Ultracet
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.
GabapentinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol hydrochloride (HCl)/ Acetaminophen | Experimental | 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. Receives: Drug: Tramadol hydrochloride/ Acetaminophen |
| Gabapentin | Active comparator | 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. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 43
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634543
- Sponsor's protocol ID
- CR012967
- Other IDs
- ULT-KOR-06
- Status last verified
- Jul 2013
- First submitted
- 6 Mar 2008
- Last updated
- 12 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00634543
- Acronym / sponsor ID
- CR012967
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetic neuropathy, Ultracet, Tramadol hydrochloride, Acetaminophen, Gabapentin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 16 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol hydrochloride (HCl)/ Acetaminophen | Experimental | Drug: Tramadol hydrochloride/ AcetaminophenParticipants 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. |
| Gabapentin | Active comparator | Drug: GabapentinParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol hydrochloride/ AcetaminophenAlso: UltracetParticipants 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 (HCl)/ Acetaminophen |
| GabapentinParticipants 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 |
Primary outcome
Change From Baseline in Pain Intensity Score at Day 43
Time frame: 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.
5 secondary outcomes
Percentage of Participants With Pain Relief
Time frame: Day 15, Day 29 and Day 43
Overall Assessment of Study Medication by Participants
Time frame: Day 43
Overall Assessment of Study Medication by Investigator
Time frame: Day 43
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Time frame: Baseline and Day 43
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Time frame: Baseline and Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol hydrochloride/ Acetaminophen and Gabapentin in people with Diabetic Neuropathy, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Intensity Score at Day 43 (time frame: Baseline and Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.