Postherpetic NeuralgiaPhase 2NCT01688947
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
A Phase 2 study testing V116517 50-mg tablets, V116517 30-mg tablets and Pregabalin capsules in people with Postherpetic Neuralgia and Pain, run by Purdue Pharma LP at 28 sites in United States.
Trial summary
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Postherpetic Neuralgia, Pain
- What is being tested?
- V116517 50-mg tablets, V116517 30-mg tablets and Pregabalin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 28 sitesUnited States
- Study dates
- Sep 2012to Apr 2014
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
- Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.
Who cannot join
- Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
- Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
- Subjects with a recent history of seizure within the past 5 years.
- Subjects who use opioids more than 4 days per week.
- Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
- Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
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- PHN-pain-condition-specific exclusions:
- Subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps.
- Active-comparator-related exclusions:
- Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.
- Other protocol specific inclusion/exclusion criteria may apply.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Investigational Site
Albuquerque, New Mexico, 87108
Investigational Site
Austin, Texas, 78731
Investigational Site
Bay City, Michigan, 48706
Investigational Site
Bingham Farms, Michigan, 48025
Investigational Site
Boca Raton, Florida, 33486
Investigational Site
Bradenton, Florida, 34205
Investigational Site
Charlotte, North Carolina, 28204
Investigational Site
Chicago, Illinois, 60634
Investigational Site
Decatur, Georgia, 30033
Investigational Site
DeLand, Florida, 32720
Investigational Site
Fort Myers, Florida, 33916
Investigational Site
La Jolla, California, 92037-7651
Investigational Site
Las Vegas, Nevada, 89123
Investigational Site
Lynn Haven, Florida, 32444
Investigational Site
New Bedford, Massachusetts, 02740
Investigational Site
North Hollywood, California, 91606
Investigational Site
North Miami, Florida, 33161
Investigational Site
Orlando, Florida, 32806
Investigational Site
Oviedo, Florida, 32765
Investigational Site
Palm Beach Gardens, Florida, 33410
Investigational Site
Pinconning, Michigan, 48650
Investigational Site
Prairie Village, Kansas, 66206
Investigational Site
Raleigh, North Carolina, 27609
Investigational Site
Salt Lake City, Utah, 84106
Investigational Site
Sarasota, Florida, 34233
Investigational Site
St. Petersburg, Florida, 33716
Investigational Site
Sunrise, Florida, 33351
Investigational Site
Tucson, Arizona, 85704
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
- Conditions
- Postherpetic Neuralgia, Pain
- Being tested
- V116517 50-mg tablets, V116517 30-mg tablets, Pregabalin capsules, Placebo
- Keywords
- Pain, Neuralgia, Postherpetic
- Medical subject headings
- Neuralgia, Postherpetic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V116517 50-mg tabletsDrug
Taken orally twice daily
V116517 30-mg tabletsDrug
Taken orally twice daily
Pregabalin capsulesDrug
1-2 capsules taken orally twice daily
PlaceboDrug
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| V116517 - 50 mg | Experimental | V116517 50-mg tablets Receives: Drug: V116517 50-mg tablets; Drug: Placebo |
| V116517 - 30 mg | Experimental | V116517 30-mg tablets Receives: Drug: V116517 30-mg tablets; Drug: Placebo |
| Pregabalin | Active comparator | Pregabalin capsules Receives: Drug: Pregabalin capsules; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
Measured: Week 4
Secondary outcomes (4)
mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)
Measured: Week 4
Neuropathic Pain Symptom Inventory (NPSI)
Measured: Week 4
Patient Global Impression of Change (PGIC)
Measured: Week 4
Supplemental Analgesic Medication Use
Measured: Over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688947
- Sponsor's protocol ID
- VND2002
- Status last verified
- May 2014
- First submitted
- 17 Sep 2012
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT01688947
- Acronym / sponsor ID
- VND2002
- Conditions
- Postherpetic Neuralgia, Pain
- Keywords
- Pain, Neuralgia, Postherpetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Sep 2012 (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 primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| V116517 - 50 mg | Experimental | Drug: V116517 50-mg tablets, Drug: PlaceboV116517 50-mg tablets |
| V116517 - 30 mg | Experimental | Drug: V116517 30-mg tablets, Drug: PlaceboV116517 30-mg tablets |
| Pregabalin | Active comparator | Drug: Pregabalin capsules, Drug: PlaceboPregabalin capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
- Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.
Key exclusion criteria (11 listed)
- Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
- Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
- Subjects with a recent history of seizure within the past 5 years.
- Subjects who use opioids more than 4 days per week.
- Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
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 |
|---|---|---|
| V116517 50-mg tabletsTaken orally twice daily | Drug | V116517 - 50 mg |
| V116517 30-mg tabletsTaken orally twice daily | Drug | V116517 - 30 mg |
| Pregabalin capsules1-2 capsules taken orally twice daily | Drug | Pregabalin |
| PlaceboTablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily | Drug | Placebo, Pregabalin, V116517 - 30 mg, V116517 - 50 mg |
Primary outcome
"Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
Time frame: Week 4
4 secondary outcomes
mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)
Time frame: Week 4
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Week 4
Patient Global Impression of Change (PGIC)
Time frame: Week 4
Supplemental Analgesic Medication Use
Time frame: Over 4 weeks
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 12 May 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.
The record lists no contact. Use the official record to reach the sponsor.
28 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 V116517 50-mg tablets, V116517 30-mg tablets and Pregabalin capsules in people with Postherpetic Neuralgia and Pain, run by Purdue Pharma LP at 28 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?
The sponsor lists 2 inclusion and 11 exclusion criteria. 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) (time frame: Week 4). 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 12 May 2014.