Neuropathic PainPAINSNCT00892008
A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
An observational study of Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Pregabalin
- How many people
- 2,278 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Aug 2008
- Phase
- Observational
- 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
Study population: Male or female, 18 years and above diagnosed with neuropathic pain.
Who may be able to join
- Male or female, 18 years old and above diagnosed with neuropathic pain.
Who cannot join
- Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.
About this study
Official title: Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.
- Conditions
- Neuropathic Pain
- Being tested
- Pregabalin
- Keywords
- pregabalin, neuropathic pain, safety
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Pregabalin 75-150 mg BID for at least 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.
Measured: Baseline through Final Visit (Week 4)
Discontinuations Due to Adverse Events
Discontinuations due to adverse events by MedDRA system organ class and preferred term.
Measured: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Secondary outcomes (9)
Change From Baseline in Visual Analogue Scale (VAS) Score
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.
Measured: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
VAS Pain Score at Baseline (BL) and Second Visit
VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .
Measured: Baseline, Second Visit (Week ≥ 2)
VAS Pain Score at Baseline and Final Visit
VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.
Measured: Baseline, Final Visit (Week 4)
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Measured: Second Visit (Week ≥ 2), Final Visit (Week 4)
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Measured: Second Visit (Week ≥ 2), Final Visit (Week 4)
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Measured: Second Visit (Week ≥ 2), Final Visit (Week 4)
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Measured: Second Visit (Week ≥ 2), Final Visit (Week 4)
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Measured: Second Visit (Week ≥ 2), Final Visit (Week 4)
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.
Measured: Second Visit (Week ≥ 2), Final Visit (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startSep 2006
- Primary completionAug 2008
- Study completionAug 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 Neuropathic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,278 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
- NCT00892008
- Sponsor's protocol ID
- A0081094
- Acronym
- PAINS
- Status last verified
- Jan 2010
- First submitted
- 30 Apr 2009
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
- Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
- ClinicalTrials.gov ID
- NCT00892008
- Acronym / sponsor ID
- PAINS / A0081094
- Conditions
- Neuropathic Pain
- Keywords
- pregabalin, neuropathic pain, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,278 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 18 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | – | Drug: PregabalinThis study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female, 18 years and above diagnosed with neuropathic pain.
Key inclusion criteria (1 listed)
- Male or female, 18 years old and above diagnosed with neuropathic pain.
Key exclusion criteria (1 listed)
- Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.
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 |
|---|---|---|
| PregabalinAlso: LyricaPregabalin 75-150 mg BID for at least 2 weeks. | Drug | Open-Label |
Primary outcome
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Time frame: Baseline through Final Visit (Week 4)
Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.
Discontinuations Due to Adverse Events
Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Discontinuations due to adverse events by MedDRA system organ class and preferred term.
9 secondary outcomes
Change From Baseline in Visual Analogue Scale (VAS) Score
Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
VAS Pain Score at Baseline (BL) and Second Visit
Time frame: Baseline, Second Visit (Week ≥ 2)
VAS Pain Score at Baseline and Final Visit
Time frame: Baseline, Final Visit (Week 4)
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 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 25 Jan 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 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?
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) (time frame: Baseline through Final Visit (Week 4)). The study lists 2 primary outcomes in all. 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.