SciaticaPhase 2NCT00991172
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain
A Phase 2 study testing REGN475 in people with Sciatica, run by Regeneron Pharmaceuticals at 30 sites in United States.
Trial summary
This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sciatica
- What is being tested?
- REGN475
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 30 sitesUnited States
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit.
- A confirmed diagnosis of sciatica at the screening visit.
- Weight less than 120 kg
Who cannot join
- Back surgery within 6 months prior to the screening visit
- Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica
- Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc.
- Allergy to doxycycline or related compounds
- Women who are pregnant or nursing
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Regeneron Investigational Site
Albuquerque, New Mexico
Regeneron Investigational Site
Anaheim, California
Regeneron Investigational Site
Atlanta, Georgia
Regeneron Investigational Site
Beverly Hills, California
Regeneron Investigational Site
Birmingham, Alabama
Regeneron Investigational Site
Cincinnati, Ohio
Regeneron Investigational Site
Clearwater, Florida
Regeneron Investigational Site
Duncansville, Pennsylvania
Regeneron Investigational Site
El Paso, Texas
Regeneron Investigational Site
Greer, South Carolina
Regeneron Investigational Site
Hallandale, Florida
Regeneron Investigational Site
Kansas City, Missouri
Regeneron Investigational Site
Memphis, Tennessee
Regeneron Investigational Site
Milford, Connecticut
Regeneron Investigational Site
Mobile, Alabama
Regeneron Investigational Site
National City, California
Regeneron Investigational Site
Overland Park, Kansas
Regeneron Investigational Site
Peoria, Arizona
Regeneron Investigational Site
Raleigh, North Carolina
Regeneron Investigational Site
Rockville, Maryland
Regeneron Investigational Site
San Antonio, Texas
Regeneron Investigational Site
Sandy Springs, Georgia
Regeneron Investigational Site
Santa Ana, California
Regeneron Investigational Site
St. Petersburg, Florida
Regeneron Investigational Site
Stamford, Connecticut
Regeneron Investigational Site
Tampa, Florida
Regeneron Investigational Site
Tyrone, Pennsylvania
Regeneron Investigational Site
Warwick, Rhode Island
Regeneron Invesitgational Site
West Jordan, Utah
Regeneron Investigational Site
West Palm Beach, Florida
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Sciatic Pain
This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.
- Conditions
- Sciatica
- Being tested
- REGN475, Placebo Injection
- Keywords
- sciatica, sciatic pain, pain, back pain
- Medical subject headings
- Sciatica, Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN475Drug
Single Subcutaneous injection dose level 1
REGN475Drug
Single subcutaneous injection dose level 2
Placebo InjectionDrug
Placebo Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| placebo injection | Placebo comparator | Not described Receives: Drug: Placebo Injection |
| active | Experimental | subcutaneous injection of REGN475 Receives: Drug: REGN475 |
| active 2 | Experimental | subcutaneous injection of REGN475 Receives: Drug: REGN475 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sciatic pain between baseline and end of week 4
Measured: 4 weeks
Secondary outcomes (1)
Additional measures of sciatic pain.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Paul Tiseo, PhD, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991172
- Sponsor's protocol ID
- R475-PN-0908
- Status last verified
- Dec 2011
- First submitted
- 4 Sep 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Sciatic Pain
- ClinicalTrials.gov ID
- NCT00991172
- Acronym / sponsor ID
- R475-PN-0908
- Conditions
- Sciatica
- Keywords
- sciatica, sciatic pain, pain, back pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Oct 2009 (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.
This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo injection | Placebo comparator | Drug: Placebo Injection |
| active | Experimental | Drug: REGN475subcutaneous injection of REGN475 |
| active 2 | Experimental | Drug: REGN475subcutaneous injection of REGN475 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit.
- A confirmed diagnosis of sciatica at the screening visit.
- Weight less than 120 kg
Key exclusion criteria (5 listed)
- Back surgery within 6 months prior to the screening visit
- Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica
- Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc.
- Allergy to doxycycline or related compounds
- Women who are pregnant or nursing
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 |
|---|---|---|
| REGN475Single Subcutaneous injection dose level 1 | Drug | active |
| REGN475Single subcutaneous injection dose level 2 | Drug | active 2 |
| Placebo InjectionPlacebo Subcutaneous injection | Drug | placebo injection |
Primary outcome
Sciatic pain between baseline and end of week 4
Time frame: 4 weeks
1 secondary outcome
Additional measures of sciatic pain.
Time frame: 6 weeks
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 8 Dec 2011.
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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.
Paul Tiseo, PhD study director
Regeneron Pharmaceuticals
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGN475 in people with Sciatica, run by Regeneron Pharmaceuticals at 30 sites in United States.
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 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: finished, as of the sponsor's last update on 8 Dec 2011. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sciatic pain between baseline and end of week 4 (time frame: 4 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 8 Dec 2011.