Painful Diabetic Neuropathy and Post Herpetic NeuralgiaPhase 4NCT00629681
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
A Phase 4 study testing Pregabalin in people with Painful Diabetic Neuropathy and Post Herpetic Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 46 sites in Germany.
Trial summary
The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy and Post Herpetic Neuralgia
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 46 sitesGermany
- Study dates
- Nov 2004to Feb 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
- Diagnosis of DPN or PHN
- Score on the Numeric Rating Scale of at least 4/10
Who cannot join
- Hospitalized patients
- Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Germany46 sites
Pfizer Investigational Site
Aachen, 52064
Pfizer Investigational Site
Albstadt, 72458
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 10435
Pfizer Investigational Site
Berlin, 13053
Pfizer Investigational Site
Bielefeld, 33604
Pfizer Investigational Site
Celle, 29221
Pfizer Investigational Site
Deggingen, 73326
Pfizer Investigational Site
Duisburg, 47051
Pfizer Investigational Site
Erbach im Odenwald, 64711
Pfizer Investigational Site
Erfurt, 99089
Pfizer Investigational Site
Frankfurt, 60311
Pfizer Investigational Site
Gera, 07548
Pfizer Investigational Site
Göppingen, 73033
Pfizer Investigational Site
Hamburg, 21073
Pfizer Investigational Site
Hamburg, 22149
Pfizer Investigational Site
Hamburg, 22607
Pfizer Investigational Site
Hemsbach, 69502
Pfizer Investigational Site
Hildesheim, 31134
Pfizer Investigational Site
Holle, 31188
Pfizer Investigational Site
Itzehoe, 25524
Pfizer Investigational Site
Karlsruhe, 76133
Pfizer Investigational Site
Karlsruhe, 76199
Pfizer Investigational Site
Katzhütte, 98746
Pfizer Investigational Site
Leer, 26789
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Limburgerhof, 67117
Pfizer Investigational Site
Lübeck, 23552
Pfizer Investigational Site
Ludwigshafen, 67061
Pfizer Investigational Site
Ludwigshafen, 67069
Pfizer Investigational Site
Lünen, 44534
Pfizer Investigational Site
Mainz, 55116
Pfizer Investigational Site
Marl, 45768
Pfizer Investigational Site
München, 81479
Pfizer Investigational Site
Münster, 48129
Pfizer Investigational Site
Osnabrück, 49078
Pfizer Investigational Site
Recklinghausen, 45657
Pfizer Investigational Site
Senftenberg, 01968
Pfizer Investigational Site
Sinsheim, 74889
Pfizer Investigational Site
Surwold, 26903
Pfizer Investigational Site
Unterhaching, 82008
Pfizer Investigational Site
Veitsbronn, 90587
Pfizer Investigational Site
Weimar, 99425
Pfizer Investigational Site
Wiesbaden, 65191
Pfizer Investigational Site
Witten, 58452
Pfizer Investigational Site
Zwönitz, 08297
About this study
Official title: Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)
- Being tested
- Pregabalin
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.
| 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.
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters
Measured: Baseline to Week 4
Secondary outcomes (11)
Mean sleep score from patient's daily sleep interference diary
Measured: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in mean sleep score from patient's daily sleep interference diary
Measured: End of treatment
Mean anxiety score from patient's daily anxiety diary
Measured: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Adverse events
Measured: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score
Measured: End of treatment
Median time to pain response profile
Measured: Over the first week
CGIC and PGIC
Measured: End of treatment
Change from baseline in EuroQOL (as measures by EQ-5D)
Measured: End of treatment
Change from baseline in mean anxiety score from patient's daily anxiety diary
Measured: End of treatment
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score
Measured: End of treatment
Course of mean pain score of patient's daily pain diary (NRS)
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startNov 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Neuropathy and Post Herpetic 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 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
- NCT00629681
- Sponsor's protocol ID
- A0081031
- Status last verified
- Apr 2011
- First submitted
- 26 Feb 2008
- Last updated
- 25 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00629681
- Acronym / sponsor ID
- A0081031
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 6 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 is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)
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 (2 listed)
- Diagnosis of DPN or PHN
- Score on the Numeric Rating Scale of at least 4/10
Key exclusion criteria (2 listed)
- Hospitalized patients
- Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
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 |
|---|---|---|
| PregabalinPregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days. | Drug | 1 |
Primary outcome
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters
Time frame: Baseline to Week 4
11 secondary outcomes
Mean sleep score from patient's daily sleep interference diary
Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in mean sleep score from patient's daily sleep interference diary
Time frame: End of treatment
Mean anxiety score from patient's daily anxiety diary
Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Adverse events
Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score
Time frame: End of treatment
Median time to pain response profile
Time frame: Over the first week
CGIC and PGIC
Time frame: End of treatment
Change from baseline in EuroQOL (as measures by EQ-5D)
Time frame: End of treatment
Change from baseline in mean anxiety score from patient's daily anxiety diary
Time frame: End of treatment
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score
Time frame: End of treatment
Course of mean pain score of patient's daily pain diary (NRS)
Time frame: Throughout the study
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 25 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Painful Diabetic Neuropathy and Post Herpetic Neuralgia
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Diabetic Neuropathy, Neuropathic Pain
RecruitingObservational study
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Chronic Pain, Acute 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.
Pfizer CT.gov Call Center study director
Pfizer
46 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 Painful Diabetic Neuropathy and Post Herpetic Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 46 sites in Germany.
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 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 25 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 46 sites in Germany. 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?
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters (time frame: Baseline to Week 4). 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 25 Jan 2021.