A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
18 Years
N/A
Both
Intractable Pain, Neoplasms
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 Center | Tucson, Arizona 85712 |
| Cancer Care Associates | Fresno, California 93720 |
| Center For Clinical Research | Winston Salem, North Carolina 27103 |
| Compassionate Cancer Care medical Group, Inc. | Fountain Valley, California 92708 |
| Christie Clinic | Champaign, Illinois 61820 |
| Montana Cancer Institute Foundation | Missoula, Montana 59802 |
| Signal Point Clinical Research Center | Middletown, Ohio 45042 |
| Hope Research Institute | Phoenix, Arizona |
| Advanced Pharma CR | Miami, Florida 33175 |
| Hematology Oncology Associates | Oakland, California 94609 |
| White Memorial Medical Center | Los Angeles, California 90033 |
| Medical Oncology Associates | Spokane, Washington 99208 |
| TriWest Research Associates | La Mesa, California 91942 |
| Better Health Clinical Research Inc | Newnan, Georgia 30265 |
| Global Scientific Innovations | Evansville, Indiana 47714 |
| Pain Research of Oregon | Eugene, Oregon 97401 |
| Hematology Oncology Associatesof Rhode Island | Cranston, Rhode Island 02920 |
| Medical Therapy and Research | San Antonio, Texas 78217 |
