Back PainPhase 2NCT01001715
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
A Phase 2 study testing REGN475/SAR164877 in people with Back Pain, run by Regeneron Pharmaceuticals at 11 sites in United States.
Trial summary
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture. Secondary objectives were: to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain; to characterize the pharmacokinetic and immunogenicity profiles… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- REGN475/SAR164877
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2009to Jan 2011
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.
Who cannot join
- Mild pain score on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
- Narcotic addiction;
- Post-fracture vertebral instability;
- Unwillingness to use study-defined rescue analgesia exclusively.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Sanofi-Aventis Investigational Site Number 840034
Atlanta, Georgia, 30328
Sanofi-Aventis Investigational Site Number 840005
Beverly Hills, California, 90211
Sanofi-Aventis Investigational Site Number 840013
Boynton Beach, Florida, 33472
Sanofi-Aventis Investigational Site Number 840047
Clearwater, Florida, 33755
Sanofi-Aventis Investigational Site Number 840044
Fort Worth, Texas, 76117
Sanofi-Aventis Investigational Site Number 840001
Fresno, California, 93710
Sanofi-Aventis Investigational Site Number 840026
New York, New York, 11201
Sanofi-Aventis Investigational Site Number 840017
Sacramento, California, 95817
Sanofi-Aventis Investigational Site Number 840028
San Diego, California, 92103
Sanofi-Aventis Investigational Site Number 840023
Southlake, Texas, 76092
Sanofi-Aventis Investigational Site Number 840008
Stockton, California, 95204
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Vertebral Fracture Associated With Osteoporosis
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture.
Secondary objectives were:
- to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
- to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.
Read the detailed description
The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.
- Conditions
- Back Pain
- Being tested
- REGN475/SAR164877, Placebo (for REGN475/SAR164877)
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN475/SAR164877Drug
Pharmaceutical form: solution
Route of administration: intravenous infusion over 30 minutes
Placebo (for REGN475/SAR164877)Drug
Pharmaceutical form: solution
Route of administration: intravenous infusion over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| REGN475/SAR164877 | Experimental | REGN475/SAR164877, single injection, dose depending on the participant's body weight Receives: Drug: REGN475/SAR164877 |
| Placebo | Placebo comparator | Placebo (for REGN475/SAR164877), single injection Receives: Drug: Placebo (for REGN475/SAR164877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]
The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit.
The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4.
Measured: baseline and 4 weeks after injection
Secondary outcomes (8)
Mean change from baseline in pain intensity as assessed by PI-NRS
Measured: baseline and every other weeks up to 12 weeks after injection
Percentage of pain-free days (score "0" pain on PI-NRS)
Measured: 12 weeks
Percentage of days with rescue analgesia use
Measured: 12 weeks
Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score
Measured: baseline and 4, 8, 12 weeks
Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
Measured: baseline and 4, 8, 12 weeks
Patient Global Impression of Change [PGIC] score
Measured: 4, 8, 12 weeks
Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
Measured: up to 12 weeks after injection
Pharmacokinetic: REGN475/SAR164877 serum concentration
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 posted27 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Business decision due to low subject recruitment and enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001715
- Sponsor's protocol ID
- ACT11308
- Status last verified
- May 2013
- First submitted
- 26 Oct 2009
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Vertebral Fracture Associated With Osteoporosis
- ClinicalTrials.gov ID
- NCT01001715
- Acronym / sponsor ID
- ACT11308
- Conditions
- Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision due to low subject recruitment and enrollment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 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.
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture.
Secondary objectives were:
- to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
- to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.
Detailed description
The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN475/SAR164877 | Experimental | Drug: REGN475/SAR164877REGN475/SAR164877, single injection, dose depending on the participant's body weight |
| Placebo | Placebo comparator | Drug: Placebo (for REGN475/SAR164877)Placebo (for REGN475/SAR164877), single injection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.
Key exclusion criteria (5 listed)
- Mild pain score on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
- Narcotic addiction;
- Post-fracture vertebral instability;
- Unwillingness to use study-defined rescue analgesia exclusively.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| REGN475/SAR164877Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes | Drug | REGN475/SAR164877 |
| Placebo (for REGN475/SAR164877)Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes | Drug | Placebo |
Primary outcome
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]
Time frame: baseline and 4 weeks after injection
The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit. The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4.
8 secondary outcomes
Mean change from baseline in pain intensity as assessed by PI-NRS
Time frame: baseline and every other weeks up to 12 weeks after injection
Percentage of pain-free days (score "0" pain on PI-NRS)
Time frame: 12 weeks
Percentage of days with rescue analgesia use
Time frame: 12 weeks
Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score
Time frame: baseline and 4, 8, 12 weeks
Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
Time frame: baseline and 4, 8, 12 weeks
Patient Global Impression of Change [PGIC] score
Time frame: 4, 8, 12 weeks
Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
Time frame: up to 12 weeks after injection
Pharmacokinetic: REGN475/SAR164877 serum concentration
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Business decision due to low subject recruitment and enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
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.
Clinical Sciences & Operations study director
Sanofi
11 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/SAR164877 in people with Back Pain, run by Regeneron Pharmaceuticals at 11 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 1 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: stopped early, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early (reason given: Business decision due to low subject recruitment and enrollment). Results are not available in the source record.
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?
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS] (time frame: baseline and 4 weeks after injection). 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 27 May 2013.