Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

An observational study of Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain. 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
Type of treatment: Pill or oral medicine
How many people: 691 participants
Where: No sites listed yet
Study dates: Sep 2006to Mar 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: Patients with neuropathic pain

Who may be able to join

Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.

Who cannot join

The patients were excluded according to the current Summary of Product Characteristics.

About this study

Official title: Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)

Read the detailed description

A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Conditions: Neuropathic Pain
Being tested: Pregabalin
Keywords: neuropathic, pain, pregabalin, Lyrica
Medical subject headings: Neuralgia, Pain

What participants receive

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

PregabalinDrug
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

Study groups in NCT00843284
Study group	Role	What they receive
Patients with neuropathic pain		Not described Receives: Drug: Pregabalin

What is being measured

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

Daily Average Pain Scores
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.
Measured: Baseline, Final Visit (Week 8 or discontinuation)
Pain Related Sleep Interference
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep
Measured: Baseline, Final Visit (Week 8 or discontinuation)

Secondary outcomes (3)

Anxiety and Depression Symptoms
The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.
Measured: Baseline, Final Visit (Week 8 or discontinuation)
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse".
Measured: Final Visit (Week 8 or discontinuation)
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse".
Measured: Final Visit (Week 8 or discontinuation)

Timeline

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

Sep 2006Mar 2008

First posted13 Feb 2009 (estimated)
Study startSep 2006
Primary completionMar 2008
Study completionMar 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: Other
Time perspective: Prospective
Enrolment: 691 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00843284
Sponsor's protocol ID: A0081139
Other IDs: ATLAS
Acronym: NI-PMS
Status last verified: Oct 2009
First submitted: 12 Feb 2009
Last updated: 10 Feb 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?

Official record

RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia

All Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)
ClinicalTrials.gov ID: NCT00843284
Acronym / sponsor ID: NI-PMS / A0081139
Conditions: Neuropathic Pain
Keywords: neuropathic, pain, pregabalin, Lyrica
Study type: Observational
Recruitment status: Completed
Enrolment: 691 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: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 13 Feb 2009 (estimated)
Results: Posted 16 Apr 2009

Clinical summary

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

Detailed description

A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with neuropathic pain	–	Drug: Pregabalin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with neuropathic pain

Key inclusion criteria (1 listed)

Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.

Key exclusion criteria (1 listed)

The patients were excluded according to the current Summary of Product Characteristics.

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
PregabalinCapsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks	Drug	Patients with neuropathic pain

Primary outcome

Daily Average Pain Scores
Time frame: Baseline, Final Visit (Week 8 or discontinuation)
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.
Pain Related Sleep Interference
Time frame: Baseline, Final Visit (Week 8 or discontinuation)
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep

3 secondary outcomes

Anxiety and Depression Symptoms
Time frame: Baseline, Final Visit (Week 8 or discontinuation)
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Time frame: Final Visit (Week 8 or discontinuation)
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Time frame: Final Visit (Week 8 or discontinuation)

Results and safety

Results posted to the registry on 16 Apr 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 (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)	691	619

Primary outcome: Daily Average Pain Scores

Time frame: Baseline, Final Visit (Week 8 or discontinuation). Mean (Standard Deviation). Unit: scores on scale

Measure	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) n = 668
Baseline	7.61 (1.69)
Final visit (Week 8 or discontinuation)	3.46 (2.11)
Change from baseline	-4.16 (2.52)

Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses): Mean Difference (Net): -4.16 (95% CI -4.35 to -3.97), p <0.0001, t-test, 2 sided

Population analysed: Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.

Primary outcome: Pain Related Sleep Interference

Time frame: Baseline, Final Visit (Week 8 or discontinuation). Mean (Standard Deviation). Unit: scores on a scale

Measure	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) n = 668
Baseline	6.28 (2.59)
Final visit (Week 8 or discontinuation)	2.27 (2.19)
Change from baseline	-4.02 (2.90)

Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses): Mean Difference (Net): -4.02 (95% CI -4.24 to -3.80), p <0.0001, t-test, 2 sided

Population analysed: Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)	7 of ?	151 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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 Neuropathic Pain

RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia

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 10 Feb 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 16 Apr 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?

Daily Average Pain Scores (time frame: Baseline, Final Visit (Week 8 or discontinuation)). 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?

On the ClinicalTrials.gov record for NCT00843284.

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 10 Feb 2021.