Peripheral NeuropathyPhase 3NCT00264875

Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

A Phase 3 study testing pregabalin in people with Peripheral Neuropathy and HIV Infections, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in 2 countries.

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

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Neuropathy, HIV Infections
What is being tested?: pregabalin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 37 sitesin 2 countries
Study dates: Feb 2006to Feb 2008
Phase: Phase 3
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

Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Who cannot join

Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
non-compliant during A0081066 trial
clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study

Trial locations and contacts

37 sites in 2 countries.

Country

City, postcode or hospital

37 sites in 2 countries

United States34 sites

Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21287-7609
Pfizer Investigational Site
Boston, Massachusetts, 02215-3318
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Dallas, Texas, 75204
Pfizer Investigational Site
Dallas, Texas, 75208-4234
Pfizer Investigational Site
Dallas, Texas, 75390-9036
Pfizer Investigational Site
Denver, Colorado, 80262
Pfizer Investigational Site
Little Rock, Arkansas, 72207
Pfizer Investigational Site
Los Angeles, California, 90025
Pfizer Investigational Site
Los Angeles, California, 90028
Pfizer Investigational Site
Miami, Florida, 33133
Pfizer Investigational Site
New York, New York, 10018
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
Pensacola, Florida, 32504-5719
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Sacramento, California, 95817-1460
Pfizer Investigational Site
Safety Harbor, Florida, 34695
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Francisco, California, 94117
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Springfield, Massachusetts, 01107
Pfizer Investigational Site
St Louis, Missouri, 63110-1010
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Stanford, California, 94305-5235
Pfizer Investigational Site
Vero Beach, Florida, 32960
Pfizer Investigational Site
West Hollywood, California, 90069
Pfizer Investigational Site
West Palm Beach, Florida, 33407

Other trials in United States

Puerto Rico3 sites

Pfizer Investigational Site
Ponce, 00716
Pfizer Investigational Site
San Juan, 00909-1711
Pfizer Investigational Site
San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Conditions: Peripheral Neuropathy, HIV Infections
Being tested: pregabalin
Medical subject headings: Peripheral Nervous System Diseases, HIV Infections

What participants receive

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

pregabalinDrug
75mg BID, titrated up to 300mg according to individual response and tolerability

Study groups in NCT00264875
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: pregabalin

What is being measured

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

Mean Visual Analogue Scale (VAS) Pain Scores
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.
Endpoint = last non-missing observation carried forward after Baseline visit.
Measured: Baseline, Week 4, Week 8, Week 12, and Endpoint

Timeline

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

Feb 2006Feb 2008

First posted13 Dec 2005 (estimated)
Study startFeb 2006
Primary completionFeb 2008
Study completionFeb 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.
Other trials for Peripheral NeuropathyStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00264875
Sponsor's protocol ID: A0081095
Status last verified: Oct 2018
First submitted: 12 Dec 2005
Last updated: 22 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Pain Phenotypes in Individuals With Multiple Sclerosis
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Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
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Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
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All Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy
ClinicalTrials.gov ID: NCT00264875
Acronym / sponsor ID: A0081095
Conditions: Peripheral Neuropathy, HIV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 13 Dec 2005 (estimated)
Results: Posted 23 Mar 2009

Clinical summary

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

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: pregabalin

Who may qualify

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

Key inclusion criteria (1 listed)

Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Key exclusion criteria (3 listed)

Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
non-compliant during A0081066 trial
clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in 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
pregabalin75mg BID, titrated up to 300mg according to individual response and tolerability	Drug	1

Primary outcome

Mean Visual Analogue Scale (VAS) Pain Scores
Time frame: Baseline, Week 4, Week 8, Week 12, and Endpoint
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.

Results and safety

Results posted to the registry on 23 Mar 2009, 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	220	190

Primary outcome: Mean Visual Analogue Scale (VAS) Pain Scores

Time frame: Baseline, Week 4, Week 8, Week 12, and Endpoint. Mean (Standard Deviation). Unit: score on scale

Measure	Pregabalin n = 220
Baseline (n=203)	38.61 (27.10)
Week 4 (n=204)	30.75 (25.19)
Week 8 (n=200)	30.16 (25.78)
Week 12 (n=207)	28.95 (26.05)
Endpoint (n=217)	29.39 (26.32)

Population analysed: The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	10 of ?	82 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Peripheral Neuropathy

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis

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.

Pfizer CT.gov Call Center study director

Pfizer

37 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin in people with Peripheral Neuropathy and HIV Infections, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 37 sites in 2 countries.

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 1 inclusion and 3 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Puerto Rico. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Mar 2009). 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?

Mean Visual Analogue Scale (VAS) Pain Scores (time frame: Baseline, Week 4, Week 8, Week 12, and Endpoint). 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 NCT00264875.

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 22 Jan 2021.