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Diabetic Peripheral NeuropathyPhase 3NCT01041859

A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

A Phase 3 study testing Tapentadol extended release (ER) in people with Diabetic Peripheral Neuropathy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 72 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who tolerated… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Peripheral Neuropathy
What is being tested?
Tapentadol extended release (ER)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
72 sitesin 3 countries
Study dates
Dec 2009to Mar 2011
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Type 1 or 2 diabetes mellitus must have a documented clinical diagnosis of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening
  • Diagnosis must include pain plus reduction or absence of pin sensibility and/or vibration sensibility on Total Neuropathy Score - Nurse (TNSn) examination in lower and/or upper extremities at screening
  • The investigator considers the patient's blood glucose to be controlled by diet, or hypoglycemics, or insulin for at least 3 months prior to enrolling in the study
  • Patients have been taking analgesic medications for the condition for at least 3 months prior to screening (patients taking opioid analgesics must be dissatisfied with current treatment, and patients taking non-opioid analgesics must be dissatisfied with current analgesia)
  • Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to <=160mg of oral morphine

Who cannot join

  • Significant history of pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia)
  • History of moderate to severe hepatic impairment
  • Severely impaired renal function
  • Clinically significant laboratory abnormalities
  • Clinically significant cardiac disease
  • History of seizure disorder or epilepsy
  • History of any other clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise patient safety during study participation

Trial locations and contacts

72 sites in 3 countries.

72 sites in 3 countries

United States60 sites

  • Study site

    Akron, Ohio

  • Study site

    Alexandria, Virginia

  • Study site

    Allentown, Pennsylvania

  • Study site

    Altoona, Pennsylvania

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Avon, Indiana

  • Study site

    Boise, Idaho

  • Study site

    Brockton, Massachusetts

  • Study site

    Bulverde, Texas

  • Study site

    Cedarhurst, New York

  • Study site

    Chandler, Arizona

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Eagle, Idaho

  • Study site

    Edina, Minnesota

  • Study site

    Evansville, Indiana

  • Study site

    Fishers, Indiana

  • Study site

    Flushing, New York

  • Study site

    Fresno, California

  • Study site

    Greer, South Carolina

  • Study site

    Hallandale, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Marietta, Georgia

  • Study site

    Medford, Oregon

  • Study site

    Meridian, Idaho

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Odessa, Texas

  • Study site

    Orange, California

  • Study site

    Ormond Beach, Florida

  • Study site

    Owings Mills, Maryland

  • Study site

    Pasadena, Maryland

  • Study site

    Phoenix, Arizona

  • Study site

    Prairie Village, Kansas

  • Study site

    Redding, California

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    Schertz, Texas

  • Study site

    Shreveport, Louisiana

  • Study site

    Spring Valley, California

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tampa, Florida

  • Study site

    Valley Stream, New York

  • Study site

    Virginia Beach, Virginia

  • Study site

    Walnut Creek, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Williamsville, New York

Other trials in United States

Canada11 sites

  • Study site

    Barrie, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Dollard-des-Ormeaux, Quebec

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Hamilton, Ontario

  • Study site

    Hawkesbury, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Laval, Quebec

  • Study site

    Montreal, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Randomized-Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability of Tapentadol Extended-Release (ER) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who tolerated tapentadol (ER) and have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

Read the detailed description

This is a randomized-withdrawal (only patients that have an initial response to tapentadol are assigned to either tapentadol or placebo), placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of orally administered tapentadol, using the extended release tamper-resistant formulation (TRF), at dosages of 100 to 250 mg twice daily in patients with moderate to severe pain due to chronic, painful DPN. The study consists of 1) an open-label (all people involved know the identity of the intervention) phase, including a 13-day screening period, a 5-day washout period (where patients are to stop taking their pain medication), a 3-day pre-titration pain-intensity evaluation period (where patients will record their pain intensity twice daily in the morning and evening), and a 3-week, open-label titration period (all patients receive tapentadol study drug), 2) a 12-week, double-blind (neither physician nor patient knows the name of the assigned drug) maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days. The study will evaluate the effectiveness of orally administered tapentadol ER versus placebo in reducing patients' pain intensity. The pain intensity will be assessed by comparing the baseline pain level to the level at week 12 of the maintenance phase. The total duration of study drug treatment for each patient will be approximately 15 weeks. Safety and tolerability will be evaluated by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), standardized neurologic examinations, and monitoring of adverse events. Patients will be titrated on tapentadol ER from a starting dose of 50 mg twice daily to the patient's optimal dose ranging between 100 mg and 250 mg twice a day, or placebo. All doses of study medication will be taken orally with approximately 120 ml of water with or without food for a maximum timeframe of 15 weeks.

Being tested
Tapentadol extended release (ER), Placebo
Keywords
Diabetic Peripheral Neuropathy, Painful, Polyneuropathy, Peripheral neuropathy
Medical subject headings
Pain, Polyneuropathies, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tapentadol extended release (ER)Drug

    Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.

  • PlaceboDrug

    Form= tablet, route= oral use. Matching placebo twice daily.

Study groups in NCT01041859
Study groupRoleWhat they receive
Tapentadol Extended Release (ER)ExperimentalNot described
Receives: Drug: Tapentadol extended release (ER)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12

    For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

    Measured: Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)

Secondary outcomes (4)

  1. Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint

    The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating "no pain" and a score of 10 indicating "pain as bad as you can imagine".

    Measured: Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)

  2. Distribution of Patient Global Impression of Change at Week 12 Endpoint

    Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is 'very much improved' and 7 is 'very much worse'

    Measured: End of Double-Blind Treatment at 12 Weeks

  3. Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint

    The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function. It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine. The pain intensity subscale score is defined as the mean of the scores from these 4 items.

    Measured: Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)

  4. Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint

    EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems. The health state index is a weighted combination of the 5 items. It has a range of 0 to 1, with 0=deceased and 1=full health.

    Measured: Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041859
Sponsor's protocol ID
CR016051
Other IDs
R331333PAI3027, KF56
Status last verified
Aug 2013
First submitted
30 Dec 2009
Last updated
11 Sep 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapentadol extended release (ER) in people with Diabetic Peripheral Neuropathy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 72 sites in 3 countries.

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 7 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 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 May 2012). 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 Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12 (time frame: Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)). 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 NCT01041859.

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 11 Sep 2013.

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