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Diabetic Neuropathy, PainfulPhase 3NCT01063868

A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

A Phase 3 study testing Tapentadol extended release (ER) in people with Diabetic Neuropathy, Painful and Diabetic Polyneuropathy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 23 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tapentadol extended release (ER)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
23 sitesUnited States
Study dates
Jan 2010to Jun 2010
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

  • Man or woman aged 18 years or older
  • 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 (this control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening)
  • 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
  • Patients with baseline score for average pain intensity in the previous 24 hours of =>4 on the 11-point numerical rating scale (NRS) at the beginning of the titration period

Who cannot join

  • Significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia, Alzheimer's disease)
  • 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

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Dallas, Texas

  • Study site

    Franklin, Indiana

  • Study site

    Fruitland Park, Florida

  • Study site

    Greenville, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Hickory, North Carolina

  • Study site

    Kettering, Ohio

  • Study site

    Libertyville, Illinois

  • Study site

    Mesa, Arizona

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    Odessa, Texas

  • Study site

    Oviedo, Florida

  • Study site

    Paducah, Kentucky

  • Study site

    San Antonio, Texas

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Virginia Beach, Virginia

  • Study site

    Wellesley Hills, Massachusetts

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A One-Year, Randomized, Open-Label, Parallel-Group, Multiple-Dose Long-Term Safety Study With Controlled Adjustment of Dose of Tapentadol Extended-Release (ER) and Oxycodone Controlled-Release (CR) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.

Read the detailed description

This is a randomized, open-label, active-controlled, multicenter study evaluating the safety profile 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) a 13-day screening period, a 3-7-day washout period (where patients are to stop taking their pain medication), a 1-day pretitration pain-intensity evaluation period (where patients will record their 24-hour pain intensity), and a 3-week, open-label titration period (patients will receive either tapentadol ER or oxycodone CR study drug in a 3 to 1 ratio), 2) a 49-week, open-label maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days. The study will evaluate the safety and tolerability of orally administered tapentadol ER by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), opioid withdrawal scales, assessment of patient-reported constipation, standardized neurologic examinations and monitoring of adverse events. Assessments of pain relief include the pain intensity numerical rating scale, and patient global impression of change scale (PGIC). The total duration of study drug treatment for each patient will be approximately 52 weeks. Titrate tapentadol ER 50 mg twice daily or oxycodone CR 10 mg twice daily to patient's optimal dose ranging between 100 mg and 250 mg twice daily or 20 and 50 mg twice daily, respectively. All doses of study medication will be taken orally with or without food for a maximum timeframe of 52 weeks.

Being tested
Tapentadol extended release (ER), Oxycodone controlled release (CR)
Keywords
Diabetic neuropathy, Painful, Polyneuropathy, Peripheral neuropathy
Medical subject headings
Diabetic Neuropathies, 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

    100, 150, 200, 250 mg twice daily for 52 weeks

  • Oxycodone controlled release (CR)Drug

    20, 30, 40, 50 mg twice daily for 52 weeks

Study groups in NCT01063868
Study groupRoleWhat they receive
001ExperimentalTapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Receives: Drug: Tapentadol extended release (ER)
002Active comparatorOxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Receives: Drug: Oxycodone controlled release (CR)

What is being measured

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

  1. Number of Subjects With Treatment-emergent Adverse Events (TEAE)

    The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.

    Measured: Entire Study

Timeline

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

  1. First posted5 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionApr 2010
  4. Study completionJun 2010

Why it stopped: Business decision

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
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01063868
Sponsor's protocol ID
CR016978
Other IDs
R331333PAI3028, KF57
Status last verified
Jan 2013
First submitted
4 Feb 2010
Last updated
4 Mar 2014
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 Neuropathy, Painful and Diabetic Polyneuropathy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 23 sites in United States.

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 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: stopped early, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. 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. 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 10 May 2011). 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?

Number of Subjects With Treatment-emergent Adverse Events (TEAE) (time frame: Entire Study). 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 NCT01063868.

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 4 Mar 2014.

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