Postherpetic NeuralgiaPhase 4NCT01264237
Evaluation of the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Neuropathic Pain
A Phase 4 study testing Etoricoxib in people with Postherpetic Neuralgia and Neuralgia, run by Analgesic Solutions at 2 sites in United Kingdom.
Trial summary
The present study will aim to determine the safety, efficacy, and tolerability of etoricoxib, an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or pain caused by abnormal activity of sensory neurons, remains undertreated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Neuralgia
- What is being tested?
- Etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2011to Apr 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Be a man or a non-pregnant, non-lactating woman 18 years and older. Women of childbearing potential should be willing to use an acceptable birth control method (at the investigator's discretion) during the study to avoid pregnancy.
- Have voluntarily provided written informed consent.
- Be able to speak, read, write, and understand English, understand the consent form, complete study related procedures, and communicate with the study staff.
- Have a clinical diagnosis of PHN by history or objective findings in the opinion of the Investigator for a minimum of 6 months. If the patient pool needs to be expanded to other neuropathic conditions, patients must meet the same criteria of patients with PHN and in addition must have a clinical diagnosis of peripheral diabetic neuropathy (PDN), idiopathic sensory neuropathy (ISN) or small fiber predominant neuropathy (SFN) by history or clinical findings in the opinion of the investigator for a minimum of 6 months.
- Have a pain intensity score averaging ≥3 on a 0-10 NRS for average daily recall over past 24 hours (at Visit 1)
- Be, in the opinion of the investigator, in generally good health (other than PHN) at screening, based upon the results of a medical history, physical examination and laboratory analysis
Who cannot join
- Are pregnant and/or lactating
- Have been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget's disease, fibromyalgia or any chronic pain syndrome that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of PHN
- Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy in an area of lumbosacral PHN
- Have any bodily moderate to severe pain (e.g., osteoarthritis) that could confound assessment or self-evaluation of pain due to PHN
- Use NSAID compounds (oral and topical) within 1 week of study and for the duration of the study
- Use opioids including tramadol within 1 week of study and for the duration of the study. (Other NP medications are allowed, provided that the doses have been stable for at least one month prior to Visit 1)
Show all 19Show fewer
- Have had neuro-ablation or neurosurgical intervention for their PHN
- Have received nerve block or intrathecal analgesia within 6 weeks of study
- Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension
- Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds
- Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator
- Have skin lesions or damage in the area where BSTK measurements are conducted (only applicable to PHN patients)
- Are undergoing active treatment for cancer, are known to be infected by HIV, or are being acutely and intensively immunosuppressed following transplantation
- Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within five years
- Known to have a condition that in the investigator's judgment precludes participation in the study
- Have a significant psychiatric disorder in the opinion of the Investigator.
- Have received an investigational drug or have used an investigational device in the 30 days prior to study entry
- Have previously been admitted to this study
- Are allergic to Arcoxia.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
MAC (UK) Neruoscience Ltd
Liverpool, L18 1HQ
Stuart Ratcliffe, MBChB, MFPM, FRSM
- Recruiting
MAC (UK) Neuroscience Ltd
Manchester, M32 0UT
Stuart Ratcliffe, MBChB, MFPM, FRSM
About this study
Official title: An Enriched Enrollment, Double-Blind, Placebo-Controlled, Parallel Group, Randomized Withdrawal Trial to Evaluate the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Moderate to Severe Neuropathic Pain
The present study will aim to determine the safety, efficacy, and tolerability of etoricoxib, an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or pain caused by abnormal activity of sensory neurons, remains undertreated. Post herpetic neuralgia (PHN), which is commonly referred to as post-shingles pain, is the most useful disease to study when investigating the efficacy of pain relievers for Neuropathic pain. Therefore, this study will primarily involve patients with PHN.
The hypothesis in this study is that etoricoxib efficacy is superior to that of placebo.
- Conditions
- Postherpetic Neuralgia, Neuralgia
- Being tested
- Etoricoxib, Placebo
- Keywords
- Postherpetic neuralgia, Neuropathic pain, Etoricoxib
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called Arcoxia
90mg Tablet QD at 10:00a.m.
PlaceboDrug
One tablet QD at 10:00a.m.
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib | Experimental | The study will use an Enriched Enrollment Randomized Withdrawal (EERW) design consisting of a 2-week open-label enrichment phase, during which subjects will receive etoricoxib. Patients who experience at least a 30% reduction in pain intensity will be randomized to either continued treatment with etoricoxib 90 mg qd or matching placebo (at a 1:1 ratio) for 4 weeks. Receives: Drug: Etoricoxib |
| Placebo | Placebo comparator | The study will use an Enriched Enrollment Randomized Withdrawal (EERW) design consisting of a 2-week open-label enrichment phase, during which subjects will receive etoricoxib, followed by a 4-week randomized, double-blind, placebo-controlled treatment phase, during which subjects will receive either etoricoxib or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Efficacy Failure
To compare the efficacy of etoricoxib to placebo in reducing pain intensity in patients with NP, as measured by Time to Efficacy Failure during the Double-Blind Period.
Measured: 28 Days
Secondary outcomes (3)
To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods
Measured: 42 Days
Time to efficacy failure by PHN sub-group based on sensory testing results
Measured: 42 Days
Safety as assessed by adverse events, serious adverse events, and vital signs
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionAug 2011 (estimated)
- Study completionApr 2012 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analgesic Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Stuart Ratcliffe, MBChB, MFPM, FRSM, Principal investigator, MAC (UK) Neuroscience Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264237
- Sponsor's protocol ID
- MRK008b-2010
- Status last verified
- Mar 2011
- First submitted
- 20 Dec 2010
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Enriched Enrollment, Double-Blind, Placebo-Controlled, Parallel Group, Randomized Withdrawal Trial to Evaluate the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Moderate to Severe Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01264237
- Acronym / sponsor ID
- MRK008b-2010
- Conditions
- Postherpetic Neuralgia, Neuralgia
- Keywords
- Postherpetic neuralgia, Neuropathic pain, Etoricoxib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Analgesic SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 21 Dec 2010 (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 present study will aim to determine the safety, efficacy, and tolerability of etoricoxib, an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or pain caused by abnormal activity of sensory neurons, remains undertreated. Post herpetic neuralgia (PHN), which is commonly referred to as post-shingles pain, is the most useful disease to study when investigating the efficacy of pain relievers for Neuropathic pain. Therefore, this study will primarily involve patients with PHN.
The hypothesis in this study is that etoricoxib efficacy is superior to that of placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib | Experimental | Drug: EtoricoxibThe study will use an Enriched Enrollment Randomized Withdrawal (EERW) design consisting of a 2-week open-label enrichment phase, during which subjects will receive etoricoxib. Patients who experience at least a 30% reduction in pain intensity will be randomized to either continued treatment with etoricoxib 90 mg qd or matching placebo (at a 1:1 ratio) for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboThe study will use an Enriched Enrollment Randomized Withdrawal (EERW) design consisting of a 2-week open-label enrichment phase, during which subjects will receive etoricoxib, followed by a 4-week randomized, double-blind, placebo-controlled treatment phase, during which subjects will receive either etoricoxib or placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be a man or a non-pregnant, non-lactating woman 18 years and older. Women of childbearing potential should be willing to use an acceptable birth control method (at the investigator's discretion) during the study to avoid pregnancy.
- Have voluntarily provided written informed consent.
- Be able to speak, read, write, and understand English, understand the consent form, complete study related procedures, and communicate with the study staff.
- Have a clinical diagnosis of PHN by history or objective findings in the opinion of the Investigator for a minimum of 6 months. If the patient pool needs to be expanded to other neuropathic conditions, patients must meet the same criteria of patients with PHN and in addition must have a clinical diagnosis of peripheral diabetic neuropathy (PDN), idiopathic sensory neuropathy (ISN) or small fiber predominant neuropathy (SFN) by history or clinical findings in the opinion of the investigator for a minimum of 6 months.
- Have a pain intensity score averaging ≥3 on a 0-10 NRS for average daily recall over past 24 hours (at Visit 1)
Key exclusion criteria (19 listed)
- Are pregnant and/or lactating
- Have been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget's disease, fibromyalgia or any chronic pain syndrome that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of PHN
- Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy in an area of lumbosacral PHN
- Have any bodily moderate to severe pain (e.g., osteoarthritis) that could confound assessment or self-evaluation of pain due to PHN
- Use NSAID compounds (oral and topical) within 1 week of study and for the duration of 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 |
|---|---|---|
| EtoricoxibAlso: Arcoxia90mg Tablet QD at 10:00a.m. | Drug | Etoricoxib |
| PlaceboOne tablet QD at 10:00a.m. | Drug | Placebo |
Primary outcome
Time to Efficacy Failure
Time frame: 28 Days
To compare the efficacy of etoricoxib to placebo in reducing pain intensity in patients with NP, as measured by Time to Efficacy Failure during the Double-Blind Period.
3 secondary outcomes
To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods
Time frame: 42 Days
Time to efficacy failure by PHN sub-group based on sensory testing results
Time frame: 42 Days
Safety as assessed by adverse events, serious adverse events, and vital signs
Time frame: 56 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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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.
Stuart Ratcliffe, MBChB, MFPM, FRSM principal investigator
MAC (UK) Neuroscience Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoricoxib in people with Postherpetic Neuralgia and Neuralgia, run by Analgesic Solutions at 2 sites in United Kingdom.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Cowles, RN (781-444-9605 ext. 121, kcowles@analgesicsolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Efficacy Failure (time frame: 28 Days). 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 23 Mar 2011.