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

October 12, 2015 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
468

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium, 2820
        • Site: 601
  • Czech Republic
      • Beroun, Czech Republic, 26601
        • Site: 903
      • Brno, Czech Republic, 60200
        • Site: 910
      • Chocen, Czech Republic, 56501
        • Site: 908
      • Litomerice, Czech Republic, 41201
        • Site: 911
      • Ostrava, Czech Republic, 71000
        • Site: 906
      • Policka, Czech Republic, 57201
        • Site: 904
      • Praha 4, Czech Republic, 14000
        • Site: 901
      • Prerov, Czech Republic, 75003
        • Site: 902
      • Rychnov nad Kneznou, Czech Republic, 51601
        • Site: 909
  • France
      • Bron, France, 69677
        • Site: 207
      • Paris, France, 75004
        • Site: 202
      • Pierre Benite, France, 69495
        • Site: 201
      • Toulouse, France, 31059
        • Site: 206
  • Germany
      • Chiemsee, Germany, 83209
        • Site: 508
      • Dresden, Germany, 1307
        • Site: 502
      • Falkensee, Germany, 14612
        • Site: 501
      • Frankfurt, Germany, 60311
        • Site: 514
      • Hamburg, Germany, 22177
        • Site: 507
      • Koln, Germany, 50937
        • Site: 509
      • Leipzig, Germany, 04109
        • Site: 505
      • Muenster, Germany, 48145
        • Site: 506
      • Wangen, Germany, 88239
        • Site: 512
  • Italy
      • Milano, Italy, 20162
        • Site: 404
      • Roma, Italy, 00133
        • Site: 401
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Site: 651
  • Poland
      • Bialystok, Poland, 15435
        • Site: 965
      • Bydgoszcz, Poland, 85822
        • Site: 961
      • Elblag, Poland, 82300
        • Site: 957
      • Gdynia, Poland, 81049
        • Site: 958
      • Katowice, Poland, 40954
        • Site: 954
      • Krakow, Poland, 31530
        • Site: 964
      • Lodz, Poland, 90153
        • Site: 951
      • Lubin, Poland, 59300
        • Site: 966
      • Poznan, Poland, 61655
        • Site: 953
      • Torun, Poland, 87100
        • Site: 959
      • Warszawa, Poland, 1868
        • Site: 960
  • Russian Federation
      • Kemerovo, Russian Federation, 150062
        • Site: 714
      • Samara, Russian Federation, 79117778999
        • Site: 708
      • Saratov, Russian Federation, 79117120826
        • Site: 709
      • St. Petersburg, Russian Federation, 191015
        • Site: 703
      • St. Petersburg, Russian Federation, 194358
        • Site: 716
      • St. Petersburg, Russian Federation, 79117120826
        • Site: 704
      • St. Petersburg, Russian Federation, 79117778999
        • Site: 706
      • Tomsk, Russian Federation, 79117778999
        • Site: 713
      • Yaroslavl, Russian Federation, 79117778999
        • Site: 711
  • Spain
      • Valencia, Spain, 46010
        • Site: 303
      • Valencia, Spain, 46014
        • Site: 304
      • Valladolid, Spain, 47012
        • Site: 305
  • Ukraine
      • Chernihiv, Ukraine, 14034
        • Site: 808
      • Kharkiv, Ukraine, 61037
        • Site: 803
      • Kvuv, Ukraine, 79010
        • Site: 812
      • Kyiv, Ukraine, 2091
        • Site: 805
      • Kyiv, Ukraine, 4053
        • Site: 807
      • Kyiv, Ukraine, 4114
        • Site: 806
      • Lviv, Ukraine, 79010
        • Site: 810
      • Mykolayiv, Ukraine, 54003
        • Site: 802
      • Odesa, Ukraine, 65009
        • Site: 801
      • Vinnitsa, Ukraine, 21010
        • Site: 813
      • Zaporizhzhya, Ukraine, 69001
        • Site: 815
  • United Kingdom
      • Chorley, United Kingdom, PR7 1PP
        • Site: 102
      • Liverpool, United Kingdom, L7 8XP
        • Site: 103
      • Poole, United Kingdom, BH15 2JB
        • Site: 104
      • Rugby, United Kingdom, CV22 5PX
        • Site: 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1. Qutenza 30 minutes + SOC
Drug: QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
Other Names:
  • Capsaisin
Experimental: 2. Qutenza 60 minutes + SOC
Drug: QUTENZA
A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
Other Names:
  • Capsaisin
No Intervention: 3. SOC
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing
Time Frame: Baseline till End of Study (up to 64 weeks)
Physicians measuring neurological function will be blinded to treatment
Baseline till End of Study (up to 64 weeks)
Tolerability of patch application by dermal assessment
Time Frame: Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)
Screening till Last visit when QUTENZA patch is applied (up to 53 weeks)
Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application
Time Frame: Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)
Assessed within 15 minutes and 60 minutes after patch removal.
Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks)
Tolerability of patch application by rescue medication use
Time Frame: Days 1 through 5 after each patch application
Days 1 through 5 after each patch application
Adverse Events and serious adverse Events
Time Frame: Screening visit through End of study visit (up to 65 weeks)
Screening visit through End of study visit (up to 65 weeks)
Vital Signs (heart rate and blood pressure)
Time Frame: Screening visit through End of study visit (up to 65 weeks)
In case of patch application to be performed within 15 minutes before topical anesthetic application and within 15 minutes after patch removal.
Screening visit through End of study visit (up to 65 weeks)
Laboratory Analyses
Time Frame: Screening visit through End of study visit (up to 65 weeks)
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.
Screening visit through End of study visit (up to 65 weeks)
Intensity of neuropathic pain using "average pain" NPRS scores
Time Frame: Screening visit through End of study visit (up to 65 weeks)
Question 5 of Brief Pain Inventory-Diabetic Neuropathy (BPI-DN)
Screening visit through End of study visit (up to 65 weeks)
Brief Pain Inventory (BPI) pain severity index and pain interference index
Time Frame: Screening visit through End of study visit (up to 65 weeks)
Screening visit through End of study visit (up to 65 weeks)
Patient Global Impression of Change
Time Frame: After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)
After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks)
Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire
Time Frame: After each patch application, from first patch application through End of Study (up to 64 weeks)
After each patch application, from first patch application through End of Study (up to 64 weeks)
Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit
Time Frame: End of Study (up to 65 weeks)
End of Study (up to 65 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Senior Clinical Study Manager, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E05-CL-3002
  • 2009-016458-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings