A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy

July 26, 2013 updated by: Janssen Korea, Ltd., Korea

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tramadol hydrochloride (HCl)/ 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.
Drug: Tramadol 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.
Other Names:
  • Ultracet
Active Comparator: Gabapentin
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 43

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Pain Relief
Time Frame: 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.
Day 15, Day 29 and Day 43
Overall Assessment of Study Medication by Participants
Time Frame: 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.
Day 43
Overall Assessment of Study Medication by Investigator
Time Frame: 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.
Day 43
Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
Time Frame: 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.
Baseline and Day 43
Change From Baseline in Short Form-36 (SF-36) Score at Day 43
Time Frame: 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.
Baseline and Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR012967
  • ULT-KOR-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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