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A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Intractable Pain, Neoplasms

Thank you

Trial Information

A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pain Measured by the Numerical Rating Scale (NRS)

Outcome Description:

• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Outcome Time Frame:

Days -5 to -1 predosing and days 3 to 14 postdosing

Safety Issue:

No

Principal Investigator

Darren Wolfe, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Diamyd Inc

Authority:

United States: Food and Drug Administration

Study ID:

NP2/P2/10/2

NCT ID:

NCT01291901

Start Date:

January 2011

Completion Date:

November 2012

Related Keywords:

  • Intractable Pain
  • Neoplasms
  • pain
  • cancer
  • malignancy
  • intractable
  • gene therapy
  • enkephalin
  • opioid
  • Neoplasms
  • Pain, Intractable

Name

Location

Arizona Clinical Research CenterTucson, Arizona  85712
Cancer Care AssociatesFresno, California  93720
Center For Clinical ResearchWinston Salem, North Carolina  27103
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Christie ClinicChampaign, Illinois  61820
Montana Cancer Institute FoundationMissoula, Montana  59802
Signal Point Clinical Research CenterMiddletown, Ohio  45042
Hope Research InstitutePhoenix, Arizona  
Advanced Pharma CRMiami, Florida  33175
Hematology Oncology AssociatesOakland, California  94609
White Memorial Medical CenterLos Angeles, California  90033
Medical Oncology AssociatesSpokane, Washington  99208
TriWest Research AssociatesLa Mesa, California  91942
Better Health Clinical Research IncNewnan, Georgia  30265
Global Scientific InnovationsEvansville, Indiana  47714
Pain Research of OregonEugene, Oregon  97401
Hematology Oncology Associatesof Rhode IslandCranston, Rhode Island  02920
Medical Therapy and ResearchSan Antonio, Texas  78217