Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01041859
Other study ID # CR016051
Secondary ID R331333PAI3027KF
Status Completed
Phase Phase 3
First received December 30, 2009
Last updated August 29, 2013
Start date December 2009
Est. completion date March 2011

Study information

Verified date August 2013
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Federal Government
Study type Interventional

Clinical 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 tapentadol (ER) and have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.


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.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tapentadol extended release (ER)
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.
Placebo
Form= tablet, route= oral use. Matching placebo twice daily.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Grünenthal GmbH

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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". Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period) No
Secondary 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". Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind) No
Secondary 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' End of Double-Blind Treatment at 12 Weeks No
Secondary 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. Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind) No
Secondary 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. Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT04638556 - Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
Completed NCT05580705 - Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT00835757 - Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy N/A
Recruiting NCT00553592 - Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes Phase 2
Recruiting NCT05863793 - Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy N/A
Withdrawn NCT05041816 - Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy N/A
Recruiting NCT06074562 - A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain Phase 2
Recruiting NCT04457531 - LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy Early Phase 1
Completed NCT02947828 - Polyneuropathy in Diabetes Mellitus Type 2
Completed NCT02056431 - Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy N/A
Completed NCT01681290 - Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes Phase 2
Completed NCT01474772 - Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) Phase 3
Completed NCT01086150 - Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy Phase 2/Phase 3
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Completed NCT04688671 - Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain Phase 2
Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
Completed NCT06130917 - Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN. N/A
Completed NCT01496365 - Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Phase 2