Postherpetic NeuralgiaPhase 2NCT01058642
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
A Phase 2 study testing ADL5747 and Pregabalin in people with Postherpetic Neuralgia, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- ADL5747 and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of PHN (defined as pain present for at least 3 months after the healing of herpes zoster rash; there is no upper limit on the duration of PHN)
- have an average daily pain score of at least 4 on the numeric pain rating scale (0-10) at the start of baseline week for Treatment Period 1 (Day -7) through the start of the first week of Treatment Period 1 (Day 1)
- be willing and able to understand and comply with protocol requirements, dietary and dosing regimens, and other protocol instructions and restrictions (for example, forgo use of their normal pain medication and other protocol specified prohibited medications for the duration of the study)
- for male participants, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the United States Food and Drug Administration (FDA) from the first dose of study medication through 30 days after the last dose of study medication on Day 49
- for female participants of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the FDA from the first dose of study medication through 30 days after the last dose of study medication on Day 49 and have negative results on a serum pregnancy test during the start of the screening period to obtain informed consent and determine eligibility for the study (Day -37 to -14) and on a urine pregnancy test during the start of the first week of Treatment Period 1 (Day 1) (women who are surgically sterile [for example, hysterectomy, tubal ligation] or postmenopausal [if ≥ 55 years old, no menses for at least 2 years; if < 55 years old, follicle stimulating hormone concentrations within the postmenopausal range of > 40 milli-International Units per milliliter (mIU/mL) and 17 β estradiol levels of < 37 picograms per milliliter (pg/mL)] are also eligible to participate)
Who cannot join
- be pregnant or lactating
- have significant skin lesions that could interfere with pain assessment
- have a history of seizures or a history of abnormal electroencephalographic results at any time (participants with a history of febrile seizures before the age of 6 years may be enrolled)
- have had previous neurolytic or neurosurgical therapy for PHN
- have had a treatment that included local anesthetic nerve blocks within 30 days before the start of the baseline week for Treatment Period 1 (Day -7)
- have any other type of pain that may impair the self-assessment of pain due to PHN
Show all 18Show fewer
- have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, hematologic, cardiovascular, metabolic, gastrointestinal, neurologic, psychiatric, or other condition that would preclude participation in the study
- have an active malignancy of any type (participants with a history of successfully treated malignancy > 5 years before the scheduled first dose of study medication and participants with treated basal or squamous cell cancer may be enrolled)
- have a medical history or condition that may interfere with drug absorption (for example, stomach resection)
- be currently using protocol specified prohibited medications in the absence of appropriate washout
- be currently taking moderate or strong inhibitors or inducers of cytochrome P450-3A (CYP3A) or inhibitors of P glycoprotein transporters
- have an estimated glomerular filtration rate (GFR) that is less than or equal to 60 mL/min calculated by the Cockcroft Gault equation or have alanine aminotransferase and/or aspartate aminotransferase levels that are at least 2 times the upper limit of normal
- have a history of substance abuse or dependence within the previous 5 years, including alcohol or positive results on the urine drug screen at start of screening period, start of baseline week, or start of the first week of Treatment Period 1 (Day -37 to Day 1); participants may be enrolled if positive results are due to medication(s) prescribed for the participant and permitted by the protocol
- have a history of suicide attempts or be judged clinically to be at serious risk of suicide
- have a score of more than 29 on the Beck Depression Inventory-II at start of screening period (Day -37 to Day -14)
- have a history of allergy to acetaminophen (the rescue medication for this study)
- have a history of intolerance to pregabalin or documented failure to respond to a maximally tolerated dose of pregabalin
- have ever received the investigational drug ADL5747 or have participated in any clinical study involving an investigational product in which they received that product within 30 days before the scheduled administration of study medication for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Laszlo J. Mate, MD
West Palm Beach, Florida, 33407-2450
About this study
Official title: A Phase 2A, Randomized, Blinded, Placebo- and Active-controlled, 2-Period Crossover Study to Assess the Analgesic Efficacy, Safety, and Tolerability of ADL5747 in Subjects With Postherpetic Neuralgia
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747.
- Conditions
- Postherpetic Neuralgia
- Being tested
- ADL5747, Placebo, Pregabalin
- Keywords
- pain, delta opioid receptor agonist
- 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.
ADL5747Drug
PlaceboDrug
PregabalinDrug
Also called Lyrica
| Study group | Role | What they receive |
|---|---|---|
| ADL5747 | Experimental | ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. Receives: Drug: ADL5747; Drug: Placebo |
| Placebo | Placebo comparator | Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. Receives: Drug: Placebo |
| Pregabalin | Active comparator | Pregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period. Receives: Drug: Placebo; Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.
Measured: Baseline, Week 2 of Treatment Period 1 or 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Wei Du, MD, Study director, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058642
- Sponsor's protocol ID
- 40CL234
- Status last verified
- Jul 2015
- First submitted
- 27 Jan 2010
- Last updated
- 30 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Blinded, Placebo- and Active-controlled, 2-Period Crossover Study to Assess the Analgesic Efficacy, Safety, and Tolerability of ADL5747 in Subjects With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT01058642
- Acronym / sponsor ID
- 40CL234
- Conditions
- Postherpetic Neuralgia
- Keywords
- pain, delta opioid receptor agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Posted 8 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADL5747 | Experimental | Drug: ADL5747, Drug: PlaceboADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. |
| Pregabalin | Active comparator | Drug: Placebo, Drug: PregabalinPregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a diagnosis of PHN (defined as pain present for at least 3 months after the healing of herpes zoster rash; there is no upper limit on the duration of PHN)
- have an average daily pain score of at least 4 on the numeric pain rating scale (0-10) at the start of baseline week for Treatment Period 1 (Day -7) through the start of the first week of Treatment Period 1 (Day 1)
- be willing and able to understand and comply with protocol requirements, dietary and dosing regimens, and other protocol instructions and restrictions (for example, forgo use of their normal pain medication and other protocol specified prohibited medications for the duration of the study)
- for male participants, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the United States Food and Drug Administration (FDA) from the first dose of study medication through 30 days after the last dose of study medication on Day 49
- for female participants of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the FDA from the first dose of study medication through 30 days after the last dose of study medication on Day 49 and have negative results on a serum pregnancy test during the start of the screening period to obtain informed consent and determine eligibility for the study (Day -37 to -14) and on a urine pregnancy test during the start of the first week of Treatment Period 1 (Day 1) (women who are surgically sterile [for example, hysterectomy, tubal ligation] or postmenopausal [if ≥ 55 years old, no menses for at least 2 years; if < 55 years old, follicle stimulating hormone concentrations within the postmenopausal range of > 40 milli-International Units per milliliter (mIU/mL) and 17 β estradiol levels of < 37 picograms per milliliter (pg/mL)] are also eligible to participate)
Key exclusion criteria (18 listed)
- be pregnant or lactating
- have significant skin lesions that could interfere with pain assessment
- have a history of seizures or a history of abnormal electroencephalographic results at any time (participants with a history of febrile seizures before the age of 6 years may be enrolled)
- have had previous neurolytic or neurosurgical therapy for PHN
- have had a treatment that included local anesthetic nerve blocks within 30 days before the start of the baseline week for Treatment Period 1 (Day -7)
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 |
|---|---|---|
| ADL5747 | Drug | ADL5747 |
| Placebo | Drug | ADL5747, Placebo, Pregabalin |
| PregabalinAlso: Lyrica | Drug | Pregabalin |
Primary outcome
Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)
Time frame: Baseline, Week 2 of Treatment Period 1 or 2
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wei Du, MD study director
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADL5747 and Pregabalin in people with Postherpetic Neuralgia, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site 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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 8 Jul 2015). 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 in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period) (time frame: Baseline, Week 2 of Treatment Period 1 or 2). 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 30 Jul 2015.