Osteoarthritis, KneePhase 2NCT01688934
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
A Phase 2 study testing V116517 50-mg tablets, V116517 30-mg tablets and Naproxen 500-mg capsules in people with Osteoarthritis, Knee and Pain, run by Purdue Pharma LP at 18 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 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- V116517 50-mg tablets, V116517 30-mg tablets and Naproxen 500-mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 2012to Aug 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with moderate pain due to OA of the knee as their primary pain condition.
- Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology [ACR] clinical and radiographic criteria):
- At least 1 of the following in addition to knee pain: age >50, stiffness <30 min, crepitus on active motion, and
- Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.
Who cannot join
- Subjects with chronic pain conditions other than OA of the knee 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 history of seizures within the past 5 years.
- Subjects who use opioids more than 4 days per week.
- Pain-condition-specific exclusions:
- Subjects who received local pain-control procedures, including intra- articular steroid injection in the study knee or intramuscular steroid injection at any site within 6 weeks of entering the study or hyaluronate injection in the study knee within 12 weeks of entering the study.
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- Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study.
- Active-comparator-related exclusions:
- Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps;
- Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease.
- Other protocol specific inclusion/exclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Orthopedic Research Institute
Boynton Beach, Florida, 33472
PMG Research of Bristol
Bristol, Tennessee, 37620
PMG Research of Charlotte, LLC.
Charlotte, North Carolina, 28209
Avail Clinical Research, LLC
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Westside Center for Clinical Research
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Health Awareness, Inc.
Jupiter, Florida, 33458
Analgesic Solutions
Natick, Massachusetts, 01760
LION Research
Norman, Oklahoma, 73069
Compass Research, LLC
Orlando, Florida, 32806
Compass Research East, LLC
Oviedo, Florida, 32765
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Genova Clinical Research, Inc.
Tucson, Arizona, 85704
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610
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 Osteoarthritis of the Knee
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- V116517 50-mg tablets, V116517 30-mg tablets, Naproxen 500-mg capsules, Placebo
- Keywords
- Pain, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
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
Naproxen 500-mg capsulesDrug
Taken orally twice daily
PlaceboDrug
Tablets to match V116517 and/or placebo capsules to match naproxen 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 |
| Naproxen 500 mg | Active comparator | Naproxen 500-mg capsules Receives: Drug: Naproxen 500-mg 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.
Western Ontario and McMaster OA Index (WOMAC) Pain Score
Measured: Week 4
Secondary outcomes (5)
WOMAC Physical Function Score
Measured: Week 4
WOMAC Stiffness Score
Measured: Week 4
Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain
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 completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 230 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
- NCT01688934
- Sponsor's protocol ID
- VND2001
- Status last verified
- Dec 2013
- First submitted
- 17 Sep 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. 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 Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01688934
- Acronym / sponsor ID
- VND2001
- Conditions
- Osteoarthritis, Knee, Pain
- Keywords
- Pain, Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (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 |
| Naproxen 500 mg | Active comparator | Drug: Naproxen 500-mg capsules, Drug: PlaceboNaproxen 500-mg capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with moderate pain due to OA of the knee as their primary pain condition.
- Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology [ACR] clinical and radiographic criteria):
Key exclusion criteria (11 listed)
- Subjects with chronic pain conditions other than OA of the knee 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 history of seizures within the past 5 years.
- Subjects who use opioids more than 4 days per week.
- Pain-condition-specific exclusions:
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 |
| Naproxen 500-mg capsulesTaken orally twice daily | Drug | Naproxen 500 mg |
| PlaceboTablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily | Drug | Naproxen 500 mg, Placebo, V116517 - 30 mg, V116517 - 50 mg |
Primary outcome
Western Ontario and McMaster OA Index (WOMAC) Pain Score
Time frame: Week 4
5 secondary outcomes
WOMAC Physical Function Score
Time frame: Week 4
WOMAC Stiffness Score
Time frame: Week 4
Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain
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 5 Dec 2013.
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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.
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 V116517 50-mg tablets, V116517 30-mg tablets and Naproxen 500-mg capsules in people with Osteoarthritis, Knee and Pain, run by Purdue Pharma LP 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?
The sponsor lists 4 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 5 Dec 2013. 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?
Western Ontario and McMaster OA Index (WOMAC) Pain Score (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 5 Dec 2013.