Diabetic Peripheral NeuropathyPhase 4NCT00159731

Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

A Phase 4 study testing Pregabalin in people with Diabetic Peripheral Neuropathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 29 sites in United States.

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 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Peripheral Neuropathy
What is being tested?: Pregabalin
How many people: 160 participants
Where: 29 sitesUnited States
Study dates: Jan 2005to May 2006
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

Adults with Type 1 or 2 diabetes
Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Who cannot join

Patients must not be in poor or unstable health.

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Pfizer Investigational Site
Albany, New York, 12205
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Englewood, New Jersey, 07631
Pfizer Investigational Site
Greenville, North Carolina, 27834
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Omaha, Nebraska, 68116
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Salt Lake City, Utah, 84108
Pfizer Investigational Site
Salt Lake City, Utah, 84132
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Sunrise, Florida, 33351
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Torrance, California, 90509
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Pfizer Investigational Site
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy

Conditions: Diabetic Peripheral Neuropathy
Being tested: Pregabalin

What participants receive

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

PregabalinDrug

What is being measured

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

Adverse events

Timeline

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

Jan 2005May 2006

First posted12 Sep 2005 (estimated)
Study startJan 2005
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00159731
Sponsor's protocol ID: A0081036
Status last verified: Jul 2006
First submitted: 8 Sep 2005
Last updated: 22 Jan 2021
Results posted: 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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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
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Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

All Diabetic 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 Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT00159731
Acronym / sponsor ID: A0081036
Conditions: Diabetic Peripheral Neuropathy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2005
Study completion: May 2006
First posted: 12 Sep 2005 (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.

Study design

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

Who may qualify

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

Key inclusion criteria (2 listed)

Adults with Type 1 or 2 diabetes
Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Key exclusion criteria (1 listed)

Patients must not be in poor or unstable health.

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
Pregabalin	Drug	–

Primary outcome

Adverse events

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Diabetic Peripheral Neuropathy

Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

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

29 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 Pregabalin in people with Diabetic Peripheral Neuropathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 29 sites 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 2 inclusion and 1 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 29 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events. 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 NCT00159731.

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.