NP2 Enkephalin For Treatment of Intractable Cancer Pain



Status:Completed
Conditions:Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:January 2011
End Date:November 2013

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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

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.

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.
We found this trial at
18
sites
Cranston, Rhode Island 02920
617
mi
from 43215
Cranston, RI
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Champaign, Illinois 61820
276
mi
from 43215
Champaign, IL
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1942
mi
from 43215
Corona, CA
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Eugene, Oregon 97401
2055
mi
from 43215
Eugene, OR
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Evansville, Indiana 47714
279
mi
from 43215
Evansville, IN
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Fresno, California 93720
1986
mi
from 43215
Fresno, CA
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La Mesa, California 91942
1942
mi
from 43215
La Mesa, CA
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Los Angeles, California 90033
1972
mi
from 43215
Los Angeles, CA
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Miami, Florida 33175
994
mi
from 43215
Miami, FL
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78
mi
from 43215
Middletown, OH
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Missoula, Montana 59802
1612
mi
from 43215
Missoula, MT
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Newnan, Georgia 30265
463
mi
from 43215
Newnan, GA
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Oakland, California 94609
2099
mi
from 43215
Oakland, CA
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Phoenix, Arizona 85050
1651
mi
from 43215
Phoenix, AZ
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San Antonio, Texas 78217
1138
mi
from 43215
San Antonio, TX
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Spokane, Washington 99208
1780
mi
from 43215
Spokane, WA
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Tucson, Arizona 85712
1636
mi
from 43215
Tucson, AZ
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Winston-Salem, North Carolina 27103
307
mi
from 43215
Winston-Salem, NC
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