Back PainPhase 3NCT01011816
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
A Phase 3 study testing BIOSTAT BIOLOGX and Saline in people with Back Pain and Chronic Low Back Pain, run by Spinal Restoration, Inc. at 20 sites in United States.
Trial summary
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption
- What is being tested?
- BIOSTAT BIOLOGX and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 20 sitesUnited States
- Study dates
- Mar 2010to May 2013
- 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
- Age 18 or older and skeletally mature.
- Voluntarily signs the subject informed consent form and agrees to the release of medical information for purposes of this study (HIPAA authorization).
- Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
- Chronic low back pain for at least 6 months.
- Pretreatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale.
- Pretreatment baseline Roland-Morris Disability Questionnaire score of at least 9 on the 24-point questionnaire.
Show all 11Show fewer
- Leg pain, if present, is of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.
- Leg pain, if present, does not extend below the knee and is no greater than 50% of low back pain as measured on a visual analog scale. If bilateral leg pain, the worst leg pain is no greater than 50% of low back pain.
- Low back pain unresponsive to at least 3 months of nonoperative care, which may include bed rest, antiinflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program.
- Diagnostic medial branch block or facet joint injection between 18 months and 2 weeks prior to the study procedure indicates no facet joint involvement.
- Diagnosis of symptomatic lumbar (L1-L2 - L5-S1) internal disc disruption (IDD), which requires confirmation of discogenic pain at one or two contiguous levels through positive provocation discography performed between 18 months and 2 weeks prior to the study procedure using pressure manometry and identification of an adjacent nonpainful disc. The disc provocation studies must precisely demonstrate concordant pain (<50 psi above opening pressure) and must demonstrate a fissure(s) in the outer one-third of the posterior or lateral anulus.
Who cannot join
- Cauda equina syndrome.
- Active malignancy or tumor as source of symptoms.
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Previous lumbar spine surgery.
- Evidence of prior lumbar vertebral body fracture.
- Disc bulge/protrusion or focal herniation at the symptomatic level(s) > 4 mm.
Show all 36Show fewer
- Presence of disc extrusion or sequestration.
- Leg pain is greater than 50% of low back pain as measured on a visual analog scale.
- Leg pain that extends below the knee.
- Lumbar intervertebral foramen stenosis at the affected level(s) resulting in significant spinal nerve root compression (effacement of the majority of periganglion fat and loss of CSF signal around the nerve rootlets).
- Symptomatic central vertebral canal stenosis or absolute sagittal vertebral canal diameter < 9mm.
- Loss of disc space height at the symptomatic level(s) greater than one-third of an adjacent normal disc (or of the expected height in the case of an L5-S1 disc).
- Spondylolisthesis (> Grade 1) with or without spondylolysis at the symptomatic level(s).
- Lumbar spondylitis or other undifferentiated spondyloarthropathy.
- Dynamic instability at the symptomatic level(s) on lumbar flexion-extension radiographs indicated by >4.5 mm of translation or angular motion >15° at L1-L2, L2-L3, or L3-L4; >20° at L4-L5; or >25° at L5-S1.
- Diagnostic medial branch block or facet joint injection indicate facet joint involvement.
- Diagnostic sacroiliac injection indicates sacroiliac joint involvement for those patients with pain in the sacral region.
- Sustained relief (>3 months) of low back pain obtained with epidural injection of corticosteroids.
- Symptomatic involvement of more than two lumbar disc levels determined from discography.
- Neurological examination shows findings of radiculopathy or a significant underlying neurological condition (motor strength <4; sensory assessment abnormal; or reflexes absent or hyperactive with clonus).
- Prior thermal intradiscal procedure (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
- Any lumbar intradiscal injection procedure other than discography (e.g., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate).
- Significant systemic disease, including unstable angina, autoimmune disease, rheumatoid arthritis, and muscular dystrophy.
- Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications; or undergoing radiation therapy.
- History of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.
- Aspirin or aspirin-containing medication taken ≤ 7 days prior to the procedure.
- Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant (fibrinogen, thrombin, aprotinin, CaCl2) used in the procedure.
- History of, or current psychiatric or psychological condition, or substance or alcohol abuse that would potentially interfere with the subject's participation in the study.
- Ongoing or previous participation in another drug or device clinical study within the previous 2 months.
- Subject known to be pregnant or nursing at time of enrollment or with plans to become pregnant within the planned length of follow-up.
- Body habitus precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible using the device.
- Concomitant conditions requiring daily oral steroid use for more than 30 days in the preceding 90 days.
- Pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims.
- Prisoner or active military personnel who would not be available for follow-up.
- Presence of ferromagnetic implants that would disallow MRI of the symptomatic disc(s).
- Active or pending workers' compensation claims.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Allegheny Pain Management
Altoona, Pennsylvania, 16602
The Spine Center
Baltimore, Maryland, 21211
Bellingham Spine Pain Specialists PS
Bellingham, Washington, 98226
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Millennium Pain Center
Bloomington, Illinois, 61701
OrthoCarolina Spine Center
Charlotte, North Carolina, 28207
Pain Control Associates of San Diego
Chula Vista, California, 91914
Cleveland Clinic
Cleveland, Ohio, 44195
Medical Advanced Pain Specialists Applied Research Center
Edina, Minnesota, 55435
NewSouth NeuroSpine Pain Center
Flowood, Mississippi, 39232
The Pain Institute, Inc
Merritt Island, Florida, 32953
Napa Pain Institute
Napa, California, 94559
OrthoNeuro, Inc.
New Albany, Ohio, 43054
HOPE Research Institute
Phoenix, Arizona, 85050
Virginia Spine Research Institute
Richmond, Virginia, 23235
California Spine Diagnostics
San Francisco, California, 94115
The Spine Institute
Santa Monica, California, 90403
Spine Specialists PA
Tyler, Texas, 75701
Advanced Pain Management
Virginia Beach, Virginia, 23454
Orthopaedic & Spine Specialists
York, Pennsylvania, 17402
About this study
Official title: A Multicenter, Randomized, Blinded, Saline-Controlled Trial of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.
Read the detailed description
The Biostat System is a combination product combining a resorbable biologic product with a delivery device system used to prepare and insert the biologic material into a lumbar intervertebral disc.
Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar intervertebral disc, which appears as fissures, cracks or tears within the internal structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain located in the low back (axial pain) but also as somatic referred pain involving the posterior hips, buttocks, lateral hips, groin, or posterior thighs.
The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies, physical examination, or symptoms alone, and is best established with meticulously conducted disc provocation studies (provocation discography) that include pressure manometry and identification of an adjacent normal disc.
This treatment and study are not designed for patients exhibiting other potential sources of chronic low back pain such as more advanced degenerative disc disease with significant loss of disc height (>33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).
- Being tested
- BIOSTAT BIOLOGX, Saline
- Keywords
- intervertebral disk
- Medical subject headings
- Back Pain, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOSTAT BIOLOGXBiological
Also called Fibrin Sealant
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
SalineDrug
Also called 0.9% w/v Sodium Chloride Injection, USP
One injection of up to 4 mL of saline using the Biostat Delivery Device
| Study group | Role | What they receive |
|---|---|---|
| BIOSTAT BIOLOGX | Experimental | One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc Receives: Biological: BIOSTAT BIOLOGX |
| Saline | Placebo comparator | One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Composite Success
Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.
Measured: 26 weeks
Secondary outcomes (2)
Visual Analog Scale for Low Back Pain
Percent of subjects achieving a minimum 30% decrease in pain from baseline.
The visual analog scale is a horizontal 100 mm line anchored on the left with the words "No Pain" and on the right with the words "Worst Possible Pain". Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject's level of low back pain experienced over the last week.
Measured: 26-weeks
Roland-Morris Disability Questionnaire Score
Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score
The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject's back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability.
Measured: 26-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionMay 2013
Why it stopped: Stopped prior to last subject's last extended follow-up visit (78 weeks) due to lack of efficacy at the primary study endpoint (26 weeks)
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back 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, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Restoration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin J Pauza, MD, Principal investigator, Spine Specialists PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011816
- Sponsor's protocol ID
- SR-BX01-2007
- Status last verified
- May 2014
- First submitted
- 9 Nov 2009
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yin W, Pauza K, Olan WJ, Doerzbacher JF, Thorne KJ. Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up. Pain Med. 2014 Jan;15(1):16-31. doi: 10.1111/pme.12249. Epub 2013 Oct 23.
PubMed 24152079Buser Z, Keulling F, Jane L, Liebenberg E, Tang J, Thorne K, Coughlin D, Lotz J. Fibrin injection stimulates early disc healing in the porcine model [NASS Abstract 199]. Spine Journal 9:105S, 2009.
Buser Z, Kuelling F, Liu J, Liebenberg E, Thorne KJ, Coughlin D, Lotz JC. Biological and biomechanical effects of fibrin injection into porcine intervertebral discs. Spine (Phila Pa 1976). 2011 Aug 15;36(18):E1201-9. doi: 10.1097/BRS.0b013e31820566b2.
PubMed 21325992Pauza K, Yin W, Olan W, Doerzbacher JF. BIOSTAT BIOLOGX(R) intradiscal fibrin sealant used for treatment of chronic low back pain caused by lumbar disc disruption: results of a 12 month, prospective multicenter pilot study. Spine Arthroplasty Society Meeting, April 27-30, 2010; New Orleans, LA. Abstract 248.
Yin W, Pauza K, Olan W, Doerzbacher JF. Long-term outcomes from a prospective, multicenter investigational device exemption (IDE) pilot study of intradiscal fibrin sealant for the treatment of discogenic pain [ISIS Abstract]. Pain Medicine 12:1446-1447, 2011
Buser Z, Liu J, Thorne KJ, Coughlin D, Lotz JC. Inflammatory response of intervertebral disc cells is reduced by fibrin sealant scaffold in vitro. J Tissue Eng Regen Med. 2014 Jan;8(1):77-84. doi: 10.1002/term.1503. Epub 2012 May 18.
PubMed 22610998
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Blinded, Saline-Controlled Trial of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
- ClinicalTrials.gov ID
- NCT01011816
- Acronym / sponsor ID
- SR-BX01-2007
- Keywords
- intervertebral disk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped prior to last subject's last extended follow-up visit (78 weeks) due to lack of efficacy at the primary study endpoint (26 weeks)
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Spinal Restoration, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 5 May 2014
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 investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.
Detailed description
The Biostat System is a combination product combining a resorbable biologic product with a delivery device system used to prepare and insert the biologic material into a lumbar intervertebral disc.
Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar intervertebral disc, which appears as fissures, cracks or tears within the internal structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain located in the low back (axial pain) but also as somatic referred pain involving the posterior hips, buttocks, lateral hips, groin, or posterior thighs.
The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies, physical examination, or symptoms alone, and is best established with meticulously conducted disc provocation studies (provocation discography) that include pressure manometry and identification of an adjacent normal disc.
This treatment and study are not designed for patients exhibiting other potential sources of chronic low back pain such as more advanced degenerative disc disease with significant loss of disc height (>33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIOSTAT BIOLOGX | Experimental | Biological: BIOSTAT BIOLOGXOne injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc |
| Saline | Placebo comparator | Drug: SalineOne injection of up to 4 mL of saline solution into a single lumbar intervertebral disc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or older and skeletally mature.
- Voluntarily signs the subject informed consent form and agrees to the release of medical information for purposes of this study (HIPAA authorization).
- Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
- Chronic low back pain for at least 6 months.
- Pretreatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale.
Key exclusion criteria (36 listed)
- Cauda equina syndrome.
- Active malignancy or tumor as source of symptoms.
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Previous lumbar spine surgery.
- Evidence of prior lumbar vertebral body fracture.
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 |
|---|---|---|
| BIOSTAT BIOLOGXAlso: Fibrin SealantOne injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device | Biological | BIOSTAT BIOLOGX |
| SalineAlso: 0.9% w/v Sodium Chloride Injection, USPOne injection of up to 4 mL of saline using the Biostat Delivery Device | Drug | Saline |
Primary outcome
Subject Composite Success
Time frame: 26 weeks
Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.
2 secondary outcomes
Visual Analog Scale for Low Back Pain
Time frame: 26-weeks
Roland-Morris Disability Questionnaire Score
Time frame: 26-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24152079Yin W, Pauza K, Olan WJ, Doerzbacher JF, Thorne KJ. Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up. Pain Med. 2014 Jan;15(1):16-31. doi: 10.1111/pme.12249. Epub 2013 Oct 23.
- BackgroundBuser Z, Keulling F, Jane L, Liebenberg E, Tang J, Thorne K, Coughlin D, Lotz J. Fibrin injection stimulates early disc healing in the porcine model [NASS Abstract 199]. Spine Journal 9:105S, 2009.
- Background: PubMed 21325992Buser Z, Kuelling F, Liu J, Liebenberg E, Thorne KJ, Coughlin D, Lotz JC. Biological and biomechanical effects of fibrin injection into porcine intervertebral discs. Spine (Phila Pa 1976). 2011 Aug 15;36(18):E1201-9. doi: 10.1097/BRS.0b013e31820566b2.
- BackgroundPauza K, Yin W, Olan W, Doerzbacher JF. BIOSTAT BIOLOGX(R) intradiscal fibrin sealant used for treatment of chronic low back pain caused by lumbar disc disruption: results of a 12 month, prospective multicenter pilot study. Spine Arthroplasty Society Meeting, April 27-30, 2010; New Orleans, LA. Abstract 248.
- BackgroundYin W, Pauza K, Olan W, Doerzbacher JF. Long-term outcomes from a prospective, multicenter investigational device exemption (IDE) pilot study of intradiscal fibrin sealant for the treatment of discogenic pain [ISIS Abstract]. Pain Medicine 12:1446-1447, 2011
- Background: PubMed 22610998Buser Z, Liu J, Thorne KJ, Coughlin D, Lotz JC. Inflammatory response of intervertebral disc cells is reduced by fibrin sealant scaffold in vitro. J Tissue Eng Regen Med. 2014 Jan;8(1):77-84. doi: 10.1002/term.1503. Epub 2012 May 18.
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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.
Kevin J Pauza, MD principal investigator
Spine Specialists PA
20 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 BIOSTAT BIOLOGX and Saline in people with Back Pain and Chronic Low Back Pain, run by Spinal Restoration, Inc. at 20 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 11 inclusion and 36 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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 5 May 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?
Subject Composite Success (time frame: 26 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 NCT01011816, which also lists 6 linked publications.
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 16 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.