Postherpetic NeuralgiaPhase 1NCT02336555
The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)
A Phase 1 study testing MK-8291 in people with Postherpetic Neuralgia, run by Merck Sharp & Dohme LLC.
Trial summary
This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia. The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- MK-8291
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2015to 29 Feb 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- non-pregnant female (and/or partner) agrees to use two acceptable methods of birth control throughout the trial until 2 weeks after the last dose of treatment
- female is postmenopausal or surgically sterile
- has a clinical diagnosis of PHN with allodynia for at least 3 months duration after healing of rash
- has a body mass index (BMI) =< 35 kg/m^2, inclusive
- is in good health, with exception of PHN
- is on a stable dose for at least 30 days prior to screening if taking any of the following: opioids, non-opioids, paracetomol, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, antidepressants
- is a nonsmoker or has not used nicotine or nicotine containing products for at least prior 3 months
Who cannot join
- has a non-PHN chronic pain state
- has a history of clinically significant and inadequately treated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- has a history of malignant cancer
- has a history or presence of esophagitis
- has a history of significant multiple and/or severe allergies (e.g. food, drug, latex), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
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- had major surgery, donated or lost approximately 500 mL of blood within 4 weeks prior to screening
- has participated in another investigational trial within 4 weeks prior to screening
- has a history of risk factors for Torsades de Pointes, has hypokalemia or hypomagnesemia
- has a history or presence of clinically significant cardiac arrhythmia, taking substances with the target of reducing heart rate and or exercising endurance sports
- has had an injection of local anesthetics or steroids in the region affected by PHN, within 35 days prior to randomization
- anticipates using prescription and non-prescription drugs or herbal remedies during trial
- consumes excessive amounts of alcoholic or caffeinated beverages
- uses cannabis, any illicit drugs, or has a history of drug (including alcohol) abuse within 12 months of screening visit
About this study
Official title: A Randomized Clinical Trial to Study the Efficacy, Safety, and Tolerability of MK-8291 in Subjects With Post-Herpetic Neuralgia With Allodynia
This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia.
The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.
- Conditions
- Postherpetic Neuralgia
- Being tested
- MK-8291, Placebo
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8291Drug
MK-8291 oral tablets
PlaceboDrug
Placebo oral tablets
| Study group | Role | What they receive |
|---|---|---|
| MK-8291 → Placebo | Experimental | In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days) Receives: Drug: MK-8291; Drug: Placebo |
| Placebo → MK-8291 | Experimental | In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days) Receives: Drug: MK-8291; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period
Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS), in the morning prior to taking study treatment at Baseline (Day 1) in each treatment period, and then daily up to Day 28 in each treatment period. The NRS assesses the intensity of Post-herpetic Neuralgia (PHN) pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). The mean score in pain intensity of Week 4 (Days 22 to 28) minus the mean score at Baseline is presented, with a negative change representing improvement (or reduction) in pain intensity. In comparison to placebo, a reduction (difference in the change from Baseline) of 1 on the 11-point NRS is expected.
Measured: Baseline and Days 22-28 of each treatment period (Up to approximately 63 days)
Secondary outcomes (1)
Percentage of Participants Achieving a 30 Percent or Greater Change From Baseline to Day 28 in Pain Intensity
Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS) in the morning before taking study treatment at Baseline (Day 1) in each treatment period, and then daily from Day 1 up to Day 28 in each treatment period. The NRS assesses the intensity of PHN pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). This was a binary outcome denoting whether the participant reported a percent change from Baseline to Week 4 (Days 22 to 28) in the mean pain intensity score greater than 30%. The percentage of participants who reported a 30% or greater change from Baseline to Day 28 of each treatment period is presented.
Measured: Baseline and Day 28 in each treatment period (Up to approximately 63 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start12 Mar 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336555
- Sponsor's protocol ID
- 8291-012
- Other IDs
- 2014-002396-28, MK-8291-012, 2014
- Status last verified
- Nov 2019
- First submitted
- 5 Jan 2015
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Study the Efficacy, Safety, and Tolerability of MK-8291 in Subjects With Post-Herpetic Neuralgia With Allodynia
- ClinicalTrials.gov ID
- NCT02336555
- Acronym / sponsor ID
- 8291-012
- Conditions
- Postherpetic Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia.
The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-8291 → Placebo | Experimental | Drug: MK-8291, Drug: PlaceboIn Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days) |
| Placebo → MK-8291 | Experimental | Drug: MK-8291, Drug: PlaceboIn Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- non-pregnant female (and/or partner) agrees to use two acceptable methods of birth control throughout the trial until 2 weeks after the last dose of treatment
- female is postmenopausal or surgically sterile
- has a clinical diagnosis of PHN with allodynia for at least 3 months duration after healing of rash
- has a body mass index (BMI) =< 35 kg/m^2, inclusive
- is in good health, with exception of PHN
Key exclusion criteria (14 listed)
- has a non-PHN chronic pain state
- has a history of clinically significant and inadequately treated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- has a history of malignant cancer
- has a history or presence of esophagitis
- has a history of significant multiple and/or severe allergies (e.g. food, drug, latex), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
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 |
|---|---|---|
| MK-8291MK-8291 oral tablets | Drug | MK-8291 → Placebo, Placebo → MK-8291 |
| PlaceboPlacebo oral tablets | Drug | MK-8291 → Placebo, Placebo → MK-8291 |
Primary outcome
Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period
Time frame: Baseline and Days 22-28 of each treatment period (Up to approximately 63 days)
Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS), in the morning prior to taking study treatment at Baseline (Day 1) in each treatment period, and then daily up to Day 28 in each treatment period. The NRS assesses the intensity of Post-herpetic Neuralgia (PHN) pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). The mean score in pain intensity of Week 4 (Days 22 to 28) minus the mean score at Baseline is presented, with a negative change representing improvement (or reduction) in pain intensity. In comparison to placebo, a reduction (difference in the change from Baseline) of 1 on the 11-point NRS is expected.
1 secondary outcome
Percentage of Participants Achieving a 30 Percent or Greater Change From Baseline to Day 28 in Pain Intensity
Time frame: Baseline and Day 28 in each treatment period (Up to approximately 63 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-8291 in people with Postherpetic Neuralgia, run by Merck Sharp & Dohme LLC.
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 7 inclusion and 14 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period (time frame: Baseline and Days 22-28 of each treatment period (Up to approximately 63 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 9 Dec 2019.