Neuropathic PainPhase 3NCT00219544
Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
A Phase 3 study testing Pregabalin (Lyrica) in people with Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 30 sites in Canada.
Trial summary
This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia). 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 (Lyrica)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 30 sitesCanada
- Study dates
- Nov 2005to Feb 2008
- Phase
- Phase 3
- 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
Who may be able to join
- Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
- At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.
Who cannot join
- Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Canada30 sites
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1
Pfizer Investigational Site
Calgary, Alberta, T2S 3C3
Pfizer Investigational Site
Calgary, Alberta, T3B 0M3
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1E 1J7
Pfizer Investigational Site
Edmonton, Alberta, T5J 3N4
Pfizer Investigational Site
Edmonton, Alberta, T5N 3Y6
Pfizer Investigational Site
Granby, Quebec, J2G 8Z9
Pfizer Investigational Site
Halifax, Nova Scotia, B3J 3T1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Laval, Quebec, H7M 3L9
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
Lévis, Quebec, G6V 3Z1
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Mirabel, Quebec, J7J 2K8
Pfizer Investigational Site
Montreal, Quebec, H3A 2B4
Pfizer Investigational Site
Montreal, Quebec, H3G 1A4
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
Port Hope, Ontario, L1A 3Y9
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 0W8
Pfizer Investigational Site
Sherbrook, Quebec, J1H 4J6
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
Ste-Foy, Quebec, G1V 4X7
Pfizer Investigational Site
Toronto, Ontario, M5G 2N2
Pfizer Investigational Site
Vancouver, British Columbia, V6E 1M7
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2E8
Pfizer Investigational Site
Winnipeg, Manitoba, R2V 4W3
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain
This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
- Conditions
- Neuropathic Pain
- Being tested
- Pregabalin (Lyrica), Placebo
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin (Lyrica)Drug
pregabalin 150mg/day (75mg BID)
Pregabalin (Lyrica)Drug
pregabalin 300 mg/day (150mg BID)
Pregabalin (Lyrica)Drug
pregabalin 600/day (300mg BID)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pregabalin (Lyrica) |
| 2 | Experimental | Not described Receives: Drug: Pregabalin (Lyrica) |
| 3 | Experimental | Not described Receives: Drug: Pregabalin (Lyrica) |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase
Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: 9 weeks
Secondary outcomes (18)
Weekly Mean Pain Scores During the Single-blind Treatment Phase
Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: 0 and 4 weeks
Weekly Mean Pain Scores During the Double Blind Treatment Phase
Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: Week 4 - 9
Change in Pain Scores During Double Blind Treatment Phase
Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: 9 weeks
Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment
Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Measured: Week 4 (end of single-blind treatment phase)
Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.
Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
Measured: Week 4
Mean Pain Score for Non-responders at End of Single-blind Treatment Phase
Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
Measured: Week 4
Categorized Daily Pain Score
Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)
Measured: Week 9
Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)
Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .
Measured: Week 9
Mean Sleep Interference Score
Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Measured: Week 9
Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase
Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Measured: 0 and 4 weeks
Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase
Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Measured: Week 9
Change in Sleep Interference Scores During Double Blind Treatment Phase
Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Measured: 9 weeks
Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)
Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: Week 4, Week 9
Change in Hospital Anxiety and Depression Scale Responses
Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.
Measured: Week 9
Change in Pain Treatment Satisfaction Scale (PTSS)
Mean Change: score from observation minus score from randomization: PTSS "Impact" module of 8-items \& "Satisfaction" module of 6-items; item scores 1-5.
Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100
=best possible response: Score =[(5 - mean non-missing items)*100]/4.
Measured: Week 9
Patient Global Impression of Change (PGIC) Categories by Number of Subjects
Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from
1 (very much improved) to 7 (very much worse).
Measured: Week 9
Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.
Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.
Measured: Week 9
Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components
two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2008
- Study completionFeb 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 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
- NCT00219544
- Sponsor's protocol ID
- A0081084
- Status last verified
- Nov 2018
- First submitted
- 13 Sep 2005
- Last updated
- 22 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00219544
- Acronym / sponsor ID
- A0081084
- Conditions
- Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 2 Jun 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 will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pregabalin (Lyrica) |
| 2 | Experimental | Drug: Pregabalin (Lyrica) |
| 3 | Experimental | Drug: Pregabalin (Lyrica) |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
- At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.
Key exclusion criteria (1 listed)
- Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
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 |
|---|---|---|
| Pregabalin (Lyrica)pregabalin 150mg/day (75mg BID) | Drug | 1 |
| Pregabalin (Lyrica)pregabalin 300 mg/day (150mg BID) | Drug | 2 |
| Pregabalin (Lyrica)pregabalin 600/day (300mg BID) | Drug | 3 |
| PlaceboPlacebo | Drug | 4 |
Primary outcome
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase
Time frame: 9 weeks
Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
18 secondary outcomes
Weekly Mean Pain Scores During the Single-blind Treatment Phase
Time frame: 0 and 4 weeks
Weekly Mean Pain Scores During the Double Blind Treatment Phase
Time frame: Week 4 - 9
Change in Pain Scores During Double Blind Treatment Phase
Time frame: 9 weeks
Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment
Time frame: Week 4 (end of single-blind treatment phase)
Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.
Time frame: Week 4
Mean Pain Score for Non-responders at End of Single-blind Treatment Phase
Time frame: Week 4
Categorized Daily Pain Score
Time frame: Week 9
Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)
Time frame: Week 9
Mean Sleep Interference Score
Time frame: Week 9
Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase
Time frame: 0 and 4 weeks
Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase
Time frame: Week 9
Change in Sleep Interference Scores During Double Blind Treatment Phase
Time frame: 9 weeks
Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)
Time frame: Week 4, Week 9
Change in Hospital Anxiety and Depression Scale Responses
Time frame: Week 9
Change in Pain Treatment Satisfaction Scale (PTSS)
Time frame: Week 9
Patient Global Impression of Change (PGIC) Categories by Number of Subjects
Time frame: Week 9
Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.
Time frame: Week 9
Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components
Time frame: Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin (Lyrica) in people with Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 30 sites in Canada.
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 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 22 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 30 sites in Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 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?
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase (time frame: 9 weeks). 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.