Diabetic NeuropathiesPhase 3NCT00210847
A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients
A Phase 3 study testing tramadol, acetaminophen in people with Diabetic Neuropathies, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- tramadol, acetaminophen
- How many people
- 313 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diagnosis of diabetic neuropathy in both lower extremities
- Lower extremity pain for at least 3 months
- Stable treatment of diabetes with drugs or diet for at least 3 months
- Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of <10%)
- Documented daily pain on at least 4 of 7 days during baseline period (pain rated at least 5 on scale of 11)
- In generally good health
- If female of childbearing potential, using acceptable method of birth control
Who cannot join
- No failed trials of tramadol HCl or tramadol HCl/acetaminophen
- No participation in more than 2 clinical trials for treatment of neuropathic pain
- No more than 2 failed trials of medications for neuropathic pain
- No use of prohibited concomitant medications
- No peripheral neuropathy caused by condition other than diabetes
- No other pain more severe than neuropathic pain
Show all 20Show fewer
- No progressive or degenerative neurological disorder
- No painful peripheral diabetic neuropathy for > 10 years
- No kidney or liver dysfunction
- Not pregnant or breast-feeding
- No unstable medical disease
- No clinically significant medical conditions
- No condition that might affect the way the body absorbs or processes the study drug
- No history of suicide attempt/tendencies
- No major psychiatric disorder in past 6 months
- No history of drug or alcohol abuse/dependance in the past 2 years
- No amputations
- No active infection of the lower extremity
- No active foot ulcer
- No use of an investigational drug in past 30 days
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy
The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
Read the detailed description
Previous studies have shown that tramadol HCl is effective in painful diabetic neuropathy. The treatment of neuropathic pain often requires the use of more than one medication, working through different mechanisms of action, to provide the best pain relief. The pain-relieving potential of tramadol HCl /acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Patients who experience painful diabetic neuropathy will be enrolled. There will be a period of up to 3 weeks during which patients will stop taking medications not allowed by the study. A 7-day baseline period will follow, during which time patients will call into an Interactive Voice Response (IVR) system every night at bedtime to record daily assessments including average daily pain and sleep interference. Patients who enter the double-blind portion of the study will be randomized (like with the toss of a coin) to receive either tramadol HCl/acetaminophen or placebo. The dose of tramadol HCl/acetaminophen or placebo will be gradually increased until the doctor determines the patient is taking an adequate dose; up to 1 or 2 tablets 4 times per day, but not more than 8 tablets per day. Every night at bedtime during the double-blind phase, patients will call the IVR system to report assessments of average daily pain, sleep interference and the number of tablets of study medication taken that day. At the end of the study, patients will be tapered off their study medication. The objective of this study is to compare the analgesic effectiveness and safety of tramadol HCl/acetaminophen versus placebo for the treatment of painful diabetic neuropathy.
1 or 2 tramadol HCl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or matching placebo by mouth up to 4 times a day for 66 days
- Conditions
- Diabetic Neuropathies
- Being tested
- tramadol, acetaminophen
- Keywords
- peripheral neuropathy, Diabetic neuropathy, pain, diabetes, extremities, neuropathy, diabetic
- Medical subject headings
- Diabetic Neuropathies, Peripheral Nervous System Diseases, Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadol, acetaminophenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the average of daily pain score recorded in the IVR system from baseline to the patient's final week of treatment with study medication.
Secondary outcomes (1)
Efficacy measured by Brief Pain Inventory, Visual Analogue Scale, Short-Form McGill Pain Questionnaire, Profile of Mood States, SF-36 Health Survey, Physician and Subject Global Impression of Change, average daily sleep interference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210847
- Sponsor's protocol ID
- CR004660
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
Freeman R, Raskin P, Hewitt DJ, Vorsanger GJ, Jordan DM, Xiang J, Rosenthal NR; CAPSS-237 Study Group. Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin. 2007 Jan;23(1):147-61. doi: 10.1185/030079906X162674.
PubMed 17257476
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00210847
- Acronym / sponsor ID
- CR004660
- Conditions
- Diabetic Neuropathies
- Keywords
- peripheral neuropathy, Diabetic neuropathy, pain, diabetes, extremities, neuropathy, diabetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Dec 2003
- Study completion
- May 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
Detailed description
Previous studies have shown that tramadol HCl is effective in painful diabetic neuropathy. The treatment of neuropathic pain often requires the use of more than one medication, working through different mechanisms of action, to provide the best pain relief. The pain-relieving potential of tramadol HCl /acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Patients who experience painful diabetic neuropathy will be enrolled. There will be a period of up to 3 weeks during which patients will stop taking medications not allowed by the study. A 7-day baseline period will follow, during which time patients will call into an Interactive Voice Response (IVR) system every night at bedtime to record daily assessments including average daily pain and sleep interference. Patients who enter the double-blind portion of the study will be randomized (like with the toss of a coin) to receive either tramadol HCl/acetaminophen or placebo. The dose of tramadol HCl/acetaminophen or placebo will be gradually increased until the doctor determines the patient is taking an adequate dose; up to 1 or 2 tablets 4 times per day, but not more than 8 tablets per day. Every night at bedtime during the double-blind phase, patients will call the IVR system to report assessments of average daily pain, sleep interference and the number of tablets of study medication taken that day. At the end of the study, patients will be tapered off their study medication. The objective of this study is to compare the analgesic effectiveness and safety of tramadol HCl/acetaminophen versus placebo for the treatment of painful diabetic neuropathy.
1 or 2 tramadol HCl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or matching placebo by mouth up to 4 times a day for 66 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of diabetic neuropathy in both lower extremities
- Lower extremity pain for at least 3 months
- Stable treatment of diabetes with drugs or diet for at least 3 months
- Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of <10%)
- Documented daily pain on at least 4 of 7 days during baseline period (pain rated at least 5 on scale of 11)
Key exclusion criteria (20 listed)
- No failed trials of tramadol HCl or tramadol HCl/acetaminophen
- No participation in more than 2 clinical trials for treatment of neuropathic pain
- No more than 2 failed trials of medications for neuropathic pain
- No use of prohibited concomitant medications
- No peripheral neuropathy caused by condition other than diabetes
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, acetaminophen | Drug | – |
Primary outcome
Change in the average of daily pain score recorded in the IVR system from baseline to the patient's final week of treatment with study medication.
1 secondary outcome
Efficacy measured by Brief Pain Inventory, Visual Analogue Scale, Short-Form McGill Pain Questionnaire, Profile of Mood States, SF-36 Health Survey, Physician and Subject Global Impression of Change, average daily sleep interference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Results publication: PubMed 17257476Freeman R, Raskin P, Hewitt DJ, Vorsanger GJ, Jordan DM, Xiang J, Rosenthal NR; CAPSS-237 Study Group. Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin. 2007 Jan;23(1):147-61. doi: 10.1185/030079906X162674.
- Clinical Study Report: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic NeuropathyLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tramadol, acetaminophen in people with Diabetic Neuropathies, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 7 inclusion and 20 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 10 Jun 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in the average of daily pain score recorded in the IVR system from baseline to the patient's final week of treatment with study medication.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210847, which also lists 1 linked publication.
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 10 Jun 2011.