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NP2 Enkephalin For Treatment of Intractable Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01291901
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : August 8, 2014
Sponsor:
Collaborators:
Paragon Biomedical
invivodata, Inc.
Information provided by (Responsible Party):
Diamyd Inc

Tracking Information
First Submitted Date  ICMJE February 4, 2011
First Posted Date  ICMJE February 9, 2011
Last Update Posted Date August 8, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
Pain Measured by the Numerical Rating Scale (NRS) [ Time Frame: Days -5 to -1 predosing and days 3 to 14 postdosing ]
• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
  • Opioid Pain Medication Usage Morphine Equivalent Units (MEU) [ Time Frame: Days -5 to -1 predosing and 3 to 14 postdosing ]
    •Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts
  • Quality of Life ECOG [ Time Frame: Baseline and Week 1, 2 and 4 ]
    •Quality of Life measured by Eastern Cooperative Oncology Group Performance Status (ECOG) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.
  • Quality of Life SF-12 [ Time Frame: Baseline and Week 1, 2 and 4 ]
    •Quality of Life measured by the 12-Item Short Form Health Survey (SF-12v2) at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.
  • Pain SF-MPQ [ Time Frame: Baseline and Week 1, 2 and 4 ]
    •Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NP2 Enkephalin For Treatment of Intractable Cancer Pain
Official Title  ICMJE A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
Brief Summary The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.
Detailed Description Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Intractable Pain
  • Neoplasms
Intervention  ICMJE
  • Biological: NP2
    NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
  • Biological: Placebo
    The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
Study Arms  ICMJE
  • Experimental: Active NP2
    Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
    Intervention: Biological: NP2
  • Placebo Comparator: Placebo
    Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2011)
32
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • Histologically confirmed malignant disease.
  • Intractable pain related to malignancy.
  • Females must be postmenopausal or practicing birth control.
  • Able to provide appropriate written consent.

Main Exclusion Criteria:

  • Positive pregnancy test prior to receiving study treatment.
  • Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).
  • Evidence of active Hepatitis B, Hepatitis C, or HIV infection.
  • Evidence of viral, bacterial, or fungal infection in the planned treatment area.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291901
Other Study ID Numbers  ICMJE NP2/P2/10/2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diamyd Inc
Study Sponsor  ICMJE Diamyd Inc
Collaborators  ICMJE
  • Paragon Biomedical
  • invivodata, Inc.
Investigators  ICMJE
Study Director: Darren Wolfe, Ph.D. Diamyd Inc
Principal Investigator: David Fink, M.D. University of Michigan
PRS Account Diamyd Inc
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP