Low Back PainPhase 4PINPOINTNCT01298466
Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study
A Phase 4 study testing Pregabalin in people with Low Back Pain and Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Neuralgia
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 2013
- 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
- Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
- Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
- Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.
- Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).
Who cannot join
- A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only.
- Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min).
- Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.
- Patients who have undergone previous surgery for back pain.
- Patients who are using high doses of opioid medication (morphine > 60 mg per day).
About this study
Official title: Open-Labeled European Study To Support The Early Identification Of Patients With Chronic Neuropathic Low Back Pain In Primary Care And To Assess The Effectiveness And Tolerability Of Pregabalin In This Population
A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.
- Conditions
- Low Back Pain, Neuralgia
- Being tested
- Pregabalin
- Keywords
- identification, chronic, neuropathic, low back pain, primary care, pregabalin
- Medical subject headings
- Low Back Pain, Neuralgia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
The investigator will administer pregabalin in a flexible dose-escalation regimen as follows: 150 mg per night for 1 week, 300 mg per day for 1 week, 450 mg per day for 1 week, then 600 mg per day through to the end of the study. Patients may change the dose of medication based on individual response and tolerability as determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline.
Measured: 12 weeks
The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
Measured: 12 weeks
Secondary outcomes (10)
The time to onset of 30% pain reduction (as measured by the NRS mean pain score).
Measured: 12 weeks
The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.
Measured: 12 weeks
The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.
Measured: 12 weeks
The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.
Measured: 12 weeks
The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.
Measured: 12 weeks
The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12).
Measured: 12 weeks
The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
Measured: 12 weeks
The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
Measured: 12 weeks
The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice.
Measured: 12 weeks
The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01298466
- Sponsor's protocol ID
- A0081256
- Acronym
- PINPOINT
- Status last verified
- Apr 2012
- First submitted
- 16 Feb 2011
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
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
- Open-Labeled European Study To Support The Early Identification Of Patients With Chronic Neuropathic Low Back Pain In Primary Care And To Assess The Effectiveness And Tolerability Of Pregabalin In This Population
- ClinicalTrials.gov ID
- NCT01298466
- Acronym / sponsor ID
- PINPOINT / A0081256
- Conditions
- Low Back Pain, Neuralgia
- Keywords
- identification, chronic, neuropathic, low back pain, primary care, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 17 Feb 2011 (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.
A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: PregabalinOpen label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
- Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
- Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.
- Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).
Key exclusion criteria (5 listed)
- A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only.
- Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min).
- Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.
- Patients who have undergone previous surgery for back pain.
- Patients who are using high doses of opioid medication (morphine > 60 mg per day).
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 |
|---|---|---|
| PregabalinThe investigator will administer pregabalin in a flexible dose-escalation regimen as follows: 150 mg per night for 1 week, 300 mg per day for 1 week, 450 mg per day for 1 week, then 600 mg per day through to the end of the study. Patients may change the dose of medication based on individual response and tolerability as determined by the investigator. | Drug | Pregabalin |
Primary outcome
The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline.
Time frame: 12 weeks
The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
Time frame: 12 weeks
10 secondary outcomes
The time to onset of 30% pain reduction (as measured by the NRS mean pain score).
Time frame: 12 weeks
The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.
Time frame: 12 weeks
The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.
Time frame: 12 weeks
The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.
Time frame: 12 weeks
The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.
Time frame: 12 weeks
The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12).
Time frame: 12 weeks
The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
Time frame: 12 weeks
The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
Time frame: 12 weeks
The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice.
Time frame: 12 weeks
The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
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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?
A Phase 4 study testing Pregabalin in people with Low Back Pain and Neuralgia, 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 4 inclusion and 5 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline. (time frame: 12 weeks). 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 22 Jan 2021.