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A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients (PACE)

Primary Purpose

Painful Diabetic Peripheral Neuropathy (PDPN)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QUTENZA

About this trial

This is an interventional treatment trial for Painful Diabetic Peripheral Neuropathy (PDPN) focused on measuring Painful Diabetic Peripheral Neuropathy, Qutenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
Stable glycemic control for at least 6 months prior to screening visit
Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit

Exclusion Criteria:

Primary pain associated with PDPN in the ankles or above
Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

1. Qutenza 30 minutes + SOC

2. Qutenza 60 minutes + SOC

3. SOC

Arm Description

Subjects randomized to this group will receive treatment optimized for them on an individual basis. The investigator will be free to provide whatever pharmacological or other treatment is considered optimal for management of the subject's pain.

Outcomes

Primary Outcome Measures

Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale

Secondary Outcome Measures

Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing

Physicians measuring neurological function will be blinded to treatment

Tolerability of patch application by dermal assessment

Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application

Assessed within 15 minutes and 60 minutes after patch removal.

Tolerability of patch application by rescue medication use

Adverse Events and serious adverse Events

Vital Signs (heart rate and blood pressure)

In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.

Laboratory Analyses

The tests performed at the screening visit will include Hematology: Red Blood Cell Count, White Blood Cell Count, Lymphocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Hemoglobin, Hematocrit and Platelets. Biochemistry: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT), Alkaline Phosphatase, Sodium, Potassium, Blood Urea Nitrogen (BUN), Creatinine and Lipid profile. Subsequent HbA1c and lipid profile follow-up will be done at bi-monthly visits. The other tests will be performed if clinically indicated.

Intensity of neuropathic pain using "average pain" NPRS scores

Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)

Brief Pain Inventory (BPI) pain severity index and pain interference index

Patient Global Impression of Change

Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire

Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit

Full Information

NCT ID

NCT01478607

First Posted

November 21, 2011

Last Updated

October 12, 2015

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01478607

Brief Title

A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

Acronym

PACE

Official Title

A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

Detailed Description

Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

Painful Diabetic Peripheral Neuropathy, Qutenza

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

468 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Qutenza 30 minutes + SOC

Arm Type

Experimental

Arm Title

2. Qutenza 60 minutes + SOC

Arm Type

Experimental

Arm Title

3. SOC

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

QUTENZA

Other Intervention Name(s)

Capsaisin

Intervention Description

A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).

Primary Outcome Measure Information:

Title

Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale

Time Frame

Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)

Secondary Outcome Measure Information:

Title

Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing

Description

Physicians measuring neurological function will be blinded to treatment

Time Frame

Baseline till End of Study (up to 64 weeks)

Title

Tolerability of patch application by dermal assessment

Time Frame

Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)

Title

Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application

Description

Assessed within 15 minutes and 60 minutes after patch removal.

Time Frame

Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)

Title

Tolerability of patch application by rescue medication use

Time Frame

Days 1 through 5 after each patch application

Title

Adverse Events and serious adverse Events

Time Frame