NeuralgiaPhase 3NCT00631943
A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
A Phase 3 study testing Pregabalin (Lyrica) in people with Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 6 sites in India.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia
- What is being tested?
- Pregabalin (Lyrica)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesIndia
- Study dates
- Nov 2004to Mar 2005
- Phase
- Phase 3
- 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
- Peripheral neuropathic pain
- Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
- Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline
Who cannot join
- (none)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560054
Pfizer Investigational Site
Bangalore, Karnataka / India, 560 034
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 004
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 013
Pfizer Investigational Site
Maharashtra, Mumbai, 400 007
Pfizer Investigational Site
Mumbai, Maharashtra, 400 012
About this study
Official title: An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain
The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain
- Conditions
- Neuralgia
- Being tested
- Pregabalin (Lyrica)
- 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
Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pregabalin (Lyrica) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)
Measured: Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean pain scores
Measured: Weeks 1 and 2 and end of treatment
Secondary outcomes (7)
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
Measured: End of treatment
Adverse events and laboratory value changes
Measured: Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean sleep interference score
Measured: Weeks 1 and 2 and end of treatment
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ
Measured: Weeks 1 and 2 and end of treatment
Change from baseline in Patient Global Impression of Change (PGIC)
Measured: Weeks 1 and 2 and end of treatment
Change from baseline in Clinical Global Impression of Change (CGIC)
Measured: Weeks 1 and 2 and end of treatment
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startNov 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 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
- NCT00631943
- Sponsor's protocol ID
- A0081068
- Status last verified
- Apr 2011
- First submitted
- 3 Mar 2008
- 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
- An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00631943
- Acronym / sponsor ID
- A0081068
- Conditions
- Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 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
- Mar 2005 (actual)
- First posted
- 10 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 evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain
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 (Lyrica) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peripheral neuropathic pain
- Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
- Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline
Key exclusion criteria (1 listed)
- (none)
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)Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days. | Drug | 1 |
Primary outcome
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)
Time frame: Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean pain scores
Time frame: Weeks 1 and 2 and end of treatment
7 secondary outcomes
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores
Time frame: End of treatment
Adverse events and laboratory value changes
Time frame: Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean sleep interference score
Time frame: Weeks 1 and 2 and end of treatment
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ
Time frame: Weeks 1 and 2 and end of treatment
Change from baseline in Patient Global Impression of Change (PGIC)
Time frame: Weeks 1 and 2 and end of treatment
Change from baseline in Clinical Global Impression of Change (CGIC)
Time frame: Weeks 1 and 2 and end of treatment
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form
Time frame: End of treatment
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 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
6 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 Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 6 sites in India.
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 3 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 6 sites in India. 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 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?
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?
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS) (time frame: Weeks 1 and 2 and end of treatment). 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.