Diabetic NeuropathiesPhase 4NCT00644748
A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
A Phase 4 study testing gabapentin in people with Diabetic Neuropathies, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 10 sites in 2 countries.
Trial summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2003to Aug 2004
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable Diabetes Mellitus 1 or 2
- Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
- No clinically significant motor deficits
- Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea
Who cannot join
- Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
- Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Brazil9 sites
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30150-221
Pfizer Investigational Site
Curitiba, Paraná, 80060-150
Pfizer Investigational Site
Fortaleza, Ceará, 60120-021
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul
Pfizer Investigational Site
Recife, Pernambuco, 52051-380
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20211-340
Pfizer Investigational Site
São Paulo, São Paulo, 01246-903
Pfizer Investigational Site
São Paulo, São Paulo, 04020-041
Pfizer Investigational Site
Taguatinga, Federal District, 72119-900
Location not given1 site
Pfizer Investigational Site
About this study
Official title: An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy
The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.
- Conditions
- Diabetic Neuropathies
- Being tested
- gabapentin
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
Gabapentin oral capsules:
Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin group | Experimental | Not described Receives: Drug: gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Mean Pain Score
Measured: Endpoint
Secondary outcomes (7)
Change from baseline Mean Pain Score
Measured: Weekly
Proportion of responding patients
Measured: Endpoint
Change from baseline Mean Pain Interference with Sleep Score
Measured: Weekly and Endpoint
Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity
Measured: Endpoint
Global Change Impression from the Patient's Point of View
Measured: Endpoint
Change from baseline in quality of life
Measured: Endpoint
Global Change Impression from the Physician's Point of View
Measured: Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMay 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644748
- Sponsor's protocol ID
- A9451004
- Status last verified
- Oct 2008
- First submitted
- 25 Mar 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00644748
- Acronym / sponsor ID
- A9451004
- Conditions
- Diabetic Neuropathies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Aug 2004 (actual)
- First posted
- 27 Mar 2008 (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.
The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gabapentin group | Experimental | Drug: gabapentin |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable Diabetes Mellitus 1 or 2
- Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
- No clinically significant motor deficits
- Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea
Key exclusion criteria (2 listed)
- Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
- Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
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 |
|---|---|---|
| gabapentinGabapentin oral capsules: Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg | Drug | Gabapentin group |
Primary outcome
Change from baseline Mean Pain Score
Time frame: Endpoint
7 secondary outcomes
Change from baseline Mean Pain Score
Time frame: Weekly
Proportion of responding patients
Time frame: Endpoint
Change from baseline Mean Pain Interference with Sleep Score
Time frame: Weekly and Endpoint
Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity
Time frame: Endpoint
Global Change Impression from the Patient's Point of View
Time frame: Endpoint
Change from baseline in quality of life
Time frame: Endpoint
Global Change Impression from the Physician's Point of View
Time frame: Endpoint
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 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gabapentin in people with Diabetic Neuropathies, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 10 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 4 inclusion and 2 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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?
Change from baseline Mean Pain Score (time frame: Endpoint). 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 2 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.