Neuropathy; Radicular, Lumbar, LumbosacralPhase 4NCT00908375

Efficacy of Pregabalin in Patients With Radicular Pain

A Phase 4 study testing Pregabalin and Sugar Pill in people with Neuropathy; Radicular, Lumbar, Lumbosacral and Failed Back Surgery Syndrome, run by Northwestern University at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis
What is being tested?: Pregabalin and Sugar Pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: May 2009to Dec 2012
Phase: Phase 4
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 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with pain in dermatomal distribution, in either cervical or lumbar region.
History of pain for more than 3 months.
History of herniated disc, spinal stenosis or failed back surgery.
A series of epidural steroid injections within the past 6 months.
Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
Patients must be cognitively capable of completing the pain questionnaires.

Who cannot join

Patients below 18 or over 65 years of age.
Patients with mostly axial spinal pain.
Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
Workmen's compensation or disability issues.
Patients with chronic depression and on depression medications.
Addiction and/or substance abuse issues.

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Patients using gabapentin or failure to respond to previous gabapentin use.
Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
History of angioedema with pregabalin use.
Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
Pregnant patients.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pain Medicine Center
Chicago, Illinois, 60610

Other trials in United States

About this study

Read the detailed description

Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.

Conditions: Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis, Herniated Disc
Being tested: Pregabalin, Sugar Pill
Keywords: Pregabalin, Radicular pain, Failed back surgery, Of greater than 3 months duration
Medical subject headings: Failed Back Surgery Syndrome, Spinal Stenosis, Intervertebral Disc Displacement

What participants receive

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

PregabalinDrug
Also called Lyrica®, Pfizer NY, NY 10017
One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Sugar PillDrug
Also called Placebo
One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Study groups in NCT00908375
Study group	Role	What they receive
Pregabalin	Active comparator	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Receives: Drug: Pregabalin
Surgar Pill	Placebo comparator	One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Receives: Drug: Sugar Pill

What is being measured

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

Pain Scores (NRS) at 3-weeks
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.
.
Measured: 3 weeks

Secondary outcomes (2)

Patient's Global Impression of Change at 3 Weeks
Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:
1. Very Much Improved
2. Much Improved
3. Minimally Improved
4. No Change
5. Minimally Worse
6. Much Worse
7. Very Much Worse
Measured: 3 weeks
Oswestry Disability Questionnaires
Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.
Measured: 3 weeks

Timeline

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

May 2009Dec 2012

First posted25 May 2009 (estimated)
Study startMay 2009
Primary completionSep 2012
Study completionDec 2012

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 Neuropathy; Radicular, Lumbar, LumbosacralStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00908375
Sponsor's protocol ID: FRA7057
Status last verified: Sep 2014
First submitted: 21 May 2009
Last updated: 13 Oct 2014
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?

See locations

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All Neuropathy; Radicular, Lumbar, Lumbosacral trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Pregabalin in Patients With Radicular Pain
ClinicalTrials.gov ID: NCT00908375
Acronym / sponsor ID: FRA7057
Conditions: Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis, Herniated Disc
Keywords: Pregabalin, Radicular pain, Failed back surgery, Of greater than 3 months duration
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: May 2009
Primary completion: Sep 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 25 May 2009 (estimated)
Results: Posted 16 Sep 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pregabalin	Active comparator	Drug: PregabalinA 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Surgar Pill	Placebo comparator	Drug: Sugar PillOne Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Patients with pain in dermatomal distribution, in either cervical or lumbar region.
History of pain for more than 3 months.
History of herniated disc, spinal stenosis or failed back surgery.
A series of epidural steroid injections within the past 6 months.
Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.

Key exclusion criteria (13 listed)

Patients below 18 or over 65 years of age.
Patients with mostly axial spinal pain.
Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
Workmen's compensation or disability issues.
Patients with chronic depression and on depression medications.

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: Lyrica®, Pfizer NY, NY 10017One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Drug	Pregabalin
Sugar PillAlso: PlaceboOne sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.	Drug	Surgar Pill

Primary outcome

Pain Scores (NRS) at 3-weeks
Time frame: 3 weeks
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .

2 secondary outcomes

Patient's Global Impression of Change at 3 Weeks
Time frame: 3 weeks
Oswestry Disability Questionnaires
Time frame: 3 weeks

Results and safety

Results posted to the registry on 16 Sep 2014, 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	20	10
Sugar Pill	19	9

Primary outcome: Pain Scores (NRS) at 3-weeks

Time frame: 3 weeks. Median (Full Range). Unit: units on a scale

Measure	Pregabalin n = 10	Sugar Pill n = 9
Value	6 (1 to 9)	3 (0 to 8)

Pregabalin vs Sugar Pill: Median Difference (Final Values): -2 (99% CI -6 to 3), p = 0.279, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	1 of 20 (5%)	0 of 20 (0%)	Not reported
Sugar Pill	2 of 19 (10.5%)	0 of 19 (0%)	Not reported

Limitations and caveats (from the sponsor): Early subject withdrawal and lost to follow-up leading to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
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.

Khalid M Malik, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 13 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 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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?

Yes. Results are posted in the registry (first posted 16 Sep 2014). 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?

Pain Scores (NRS) at 3-weeks (time frame: 3 weeks). 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 NCT00908375.

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 13 Oct 2014.