Neuralgia, PostherpeticPhase 1NCT00570310

Neuropathic Pain Syndrome Patient Study (MK-0000-072)

A Phase 1 study testing Comparator: pregabalin in people with Neuralgia, Postherpetic and Diabetic Neuropathy, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy
What is being tested?: Comparator: pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: No sites listed yet
Study dates: Dec 2007to Sep 2008
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

Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
Patient is able to complete questionnaires in either English or Spanish
Patient is at least 18 years of age

Who cannot join

Patient is either pregnant or breastfeeding
Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
Patient has a history of congestive heart failure
Patient has a seizure disorder
Patient has a history of drug and/or alcohol abuse within the past 1 year
Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain

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Patient has had cancer (except basal cell carcinoma) within the past two years
Patient anticipates the need for surgery while participating in the study
Patient has a reported history of hepatitis B, C, or HIV infection
Patient has another type of pain that is more painful than the nerve pain
Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
Patient is involved in litigation or receives worker's compensation related to nerve pain

About this study

Official title: A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug

Conditions: Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
Being tested: Comparator: pregabalin, Comparator: Placebo (unspecified)
Medical subject headings: Neuralgia, Postherpetic, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: pregabalinDrug
pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
Comparator: Placebo (unspecified)Drug
pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Study groups in NCT00570310
Study group	Role	What they receive
A	Active comparator	Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period. Receives: Drug: Comparator: pregabalin
B	Placebo comparator	Patients in Group B will be treated with placebo. Receives: Drug: Comparator: Placebo (unspecified)

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily Evening Patient Reported Pain Intensity Scores
Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)
Measured: Baseline and 6 Weeks

Secondary outcomes (1)

'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study
Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)
Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Sep 2008

First posted10 Dec 2007 (estimated)
Study startDec 2007
Primary completionSep 2008
Study completionSep 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuralgia, PostherpeticStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00570310
Sponsor's protocol ID: 0000-072
Other IDs: 2007_650
Status last verified: Apr 2015
First submitted: 7 Dec 2007
Last updated: 7 May 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain. Pain. 2011 Mar;152(3):514-521. doi: 10.1016/j.pain.2010.10.050. Epub 2010 Dec 23.
PubMed 21185118

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
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Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
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The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
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Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
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All Neuralgia, Postherpetic trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug
ClinicalTrials.gov ID: NCT00570310
Acronym / sponsor ID: 0000-072
Conditions: Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 10 Dec 2007 (estimated)
Results: Posted 5 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Comparator: pregabalinPatients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.
B	Placebo comparator	Drug: Comparator: Placebo (unspecified)Patients in Group B will be treated with placebo.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
Patient is able to complete questionnaires in either English or Spanish
Patient is at least 18 years of age

Key exclusion criteria (12 listed)

Patient is either pregnant or breastfeeding
Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
Patient has a history of congestive heart failure
Patient has a seizure disorder
Patient has a history of drug and/or alcohol abuse within the past 1 year

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
Comparator: pregabalinpregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks	Drug	A
Comparator: Placebo (unspecified)pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks	Drug	B

Primary outcome

Daily Evening Patient Reported Pain Intensity Scores
Time frame: Baseline and 6 Weeks
Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)

1 secondary outcome

'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study
Time frame: 6 Weeks

Results and safety

Results posted to the registry on 5 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	53	51
Placebo	51	45

Primary outcome: Daily Evening Patient Reported Pain Intensity Scores

Time frame: Baseline and 6 Weeks. Least squares mean (Full Range). Unit: Units on a Scale

Measure	Pregabalin n = 30	Placebo n = 32
Value	0.14 (-2.00 to 4.33)	1.57 (-1.83 to 8.00)

Pregabalin vs Placebo: Mean Difference (Final Values): -1.42 (90% CI -2.25 to -0.60), p = 0.003, ANOVA

Population analysed: Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The reported AEs were collected after patients were randomized to the double-blind withdrawal period of the study. AEs that were collected prior to randomization are not reported in this document.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	0 of 51 (0%)	37 of 51 (72.5%)	Not reported
Placebo	1 of 53 (1.9%)	36 of 53 (67.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21185118Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain. Pain. 2011 Mar;152(3):514-521. doi: 10.1016/j.pain.2010.10.050. Epub 2010 Dec 23.

Related trials for Neuralgia, Postherpetic

Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
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Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Comparator: pregabalin in people with Neuralgia, Postherpetic and Diabetic Neuropathy, 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 3 inclusion and 12 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 7 May 2015. 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. 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 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 5 Feb 2010). 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?

Daily Evening Patient Reported Pain Intensity Scores (time frame: Baseline and 6 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00570310, which also lists 1 linked publication.

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 7 May 2015.