Intractable PainPhase 2NCT01291901
NP2 Enkephalin For Treatment of Intractable Cancer Pain
A Phase 2 study testing NP2 in people with Intractable Pain and Neoplasms, run by Diamyd Inc at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Pain, Neoplasms
- What is being tested?
- NP2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2011to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Christie Clinic
Champaign, Illinois, 61820
Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92879
Hematology Oncology Associatesof Rhode Island
Cranston, Rhode Island, 02920
Pain Research of Oregon
Eugene, Oregon, 97401
Global Scientific Innovations
Evansville, Indiana, 47714
Cancer Care Associates
Fresno, California, 93720
TriWest Research Associates
La Mesa, California, 91942
White Memorial Medical Center
Los Angeles, California, 90033
Advanced Pharma CR
Miami, Florida, 33175
Signal Point Clinical research Center
Middletown, Ohio, 45042
Montana Cancer Institute Foundation
Missoula, Montana, 59802
Better Health Clinical Research Inc
Newnan, Georgia, 30265
Hematology Oncology Associates
Oakland, California, 94609
HOPE Research Institute
Phoenix, Arizona, 85050
Medical Therapy and Research
San Antonio, Texas, 78217
Medical Oncology Associates
Spokane, Washington, 99208
Arizona Clinical Research Center
Tucson, Arizona, 85715
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
Read the 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.
- Conditions
- Intractable Pain, Neoplasms
- Being tested
- NP2, Placebo
- Keywords
- pain, cancer, malignancy, intractable, gene therapy, enkephalin, opioid
- Medical subject headings
- Pain, Intractable, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP2Biological
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.
PlaceboBiological
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 group | Role | What they receive |
|---|---|---|
| Active NP2 | Experimental | 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. Receives: Biological: NP2 |
| Placebo | Placebo comparator | 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measured by the Numerical Rating Scale (NRS)
- Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.
Measured: Days -5 to -1 predosing and days 3 to 14 postdosing
Secondary outcomes (4)
Opioid Pain Medication Usage Morphine Equivalent Units (MEU)
•Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts
Measured: Days -5 to -1 predosing and 3 to 14 postdosing
Quality of Life ECOG
•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.
Measured: Baseline and Week 1, 2 and 4
Quality of Life SF-12
•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.
Measured: Baseline and Week 1, 2 and 4
Pain SF-MPQ
•Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts
Measured: Baseline and Week 1, 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamyd Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paragon Biomedical, invivodata, Inc.
- Responsible party
- Sponsor
- Investigators
- Darren Wolfe, Ph.D., Study director, Diamyd IncDavid Fink, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291901
- Sponsor's protocol ID
- NP2/P2/10/2
- Status last verified
- Jul 2014
- First submitted
- 4 Feb 2011
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
- ClinicalTrials.gov ID
- NCT01291901
- Acronym / sponsor ID
- NP2/P2/10/2
- Conditions
- Intractable Pain, Neoplasms
- Keywords
- pain, cancer, malignancy, intractable, gene therapy, enkephalin, opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Diamyd IncIndustry (pharma, biotech, devices)
- Collaborators
- Paragon Biomedical, invivodata, Inc.
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active NP2 | Experimental | Biological: NP2Single 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. |
| Placebo | Placebo comparator | Biological: PlaceboSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP2NP2 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 | Active NP2 |
| PlaceboThe 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. | Biological | Placebo |
Primary outcome
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.
4 secondary outcomes
Opioid Pain Medication Usage Morphine Equivalent Units (MEU)
Time frame: Days -5 to -1 predosing and 3 to 14 postdosing
Quality of Life ECOG
Time frame: Baseline and Week 1, 2 and 4
Quality of Life SF-12
Time frame: Baseline and Week 1, 2 and 4
Pain SF-MPQ
Time frame: Baseline and Week 1, 2 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Wolfe, Ph.D. study director
Diamyd Inc
David Fink, M.D. principal investigator
University of Michigan
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NP2 in people with Intractable Pain and Neoplasms, run by Diamyd Inc at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Measured by the Numerical Rating Scale (NRS) (time frame: Days -5 to -1 predosing and days 3 to 14 postdosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.