Urinary Incontinence (UI)BE-DRINCT00090584

Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

A study testing Tolterodine and Behavioral training in people with Urinary Incontinence (UI), run by Carelon Research at 9 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence. Read more about this study

Who is it for?: Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Urinary Incontinence (UI)
What is being tested?: Tolterodine and Behavioral training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 307 participants
Where: 9 sitesUnited States
Study dates: Aug 2004to Aug 2006
Phase: Interventional
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 21 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female
Urge predominant incontinence
Incontinent > 3 mos
Available for 8 mos of followup

Who cannot join

Pregnancy or < 6 mos post-partum
Hypersensitivity to drug (tolterodine)
Systemic disease that affects bladder function (e.g., Parkinson's disease, Multiple Sclerosis, spinal cord injury)
History of extensive behavior treatment

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

University of Maryland
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35233
University of Texas Southwestern
Dallas, Texas, 75390
Loyola University Medical Center
Maywood, Illinois, 60153
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oakwood Hospital and Medical Center
Royal Oak, Michigan, 48123
University of Utah
Salt Lake City, Utah, 84132
University of Texas Health Sciences Center
San Antonio, Texas, 78229
University of California
San Diego, California, 92103

Other trials in United States

About this study

Official title: Behavior Enhances Drug Reduction of Incontinence

Conditions: Urinary Incontinence (UI)
Being tested: Tolterodine, Behavioral training
Keywords: Urge urinary incontinence (UUI), Drug/Behavior treatment
Medical subject headings: Urinary Incontinence, Urinary Incontinence, Urge

What participants receive

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

TolterodineDrug
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
Behavioral trainingBehavioural
Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.

Study groups in NCT00090584
Study group	Role	What they receive
Combination therapy	Experimental	Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training. Receives: Drug: Tolterodine; Behavioral: Behavioral training
Drug therapy alone	Active comparator	Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only. Receives: Drug: Tolterodine

What is being measured

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

Proportion of Women Who Meet Definition of Success
Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.
Measured: 8 months

Secondary outcomes (8)

Change in Incontinence Episodes
Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.
Measured: Baseline and 10 weeks
Change in Voids Per Day
Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary
Measured: baseline and 10 weeks
Symptom Distress
Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
Measured: baseline, 10 weeks and 8 months
Symptom Bother
Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.
Measured: baseline, 10 weeks and 8 months
Satisfaction
Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
Measured: 10 weeks
Satisfaction
Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
Measured: 8 months
Symptom Improvement
Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"
Measured: 10 weeks
Symptom Improvement
Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"
Measured: 8 months

Timeline

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

Aug 2004Aug 2006

First posted31 Aug 2004 (estimated)
Study startAug 2004
Primary completionDec 2005
Study completionAug 2006

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 (13)Papers the sponsor has linked to this study.
Other trials for Urinary Incontinence (UI)Studies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00090584
Sponsor's protocol ID: BE-DRI (completed)
Acronym: BE-DRI
Status last verified: May 2013
First submitted: 27 Aug 2004
Last updated: 17 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Urinary Incontinence Treatment Network (UITN). Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study. Contemp Clin Trials. 2007 Jan;28(1):48-58. doi: 10.1016/j.cct.2006.06.002. Epub 2006 Jun 18.
PubMed 16919506
Borello-France D, Burgio KL, Goode PS, Markland AD, Kenton K, Balasubramanyam A, Stoddard AM; Urinary Incontinence Treatment Network. Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. Phys Ther. 2010 Oct;90(10):1493-505. doi: 10.2522/ptj.20080387. Epub 2010 Jul 29.
PubMed 20671098
Brubaker L, Lukacz ES, Burgio K, Zimmern P, Norton P, Leng W, Johnson H, Kraus S, Stoddard A. Mixed incontinence: comparing definitions in non-surgical patients. Neurourol Urodyn. 2011 Jan;30(1):47-51. doi: 10.1002/nau.20922.
PubMed 21181960
Burgio KL, Kraus SR, Borello-France D, Chai TC, Kenton K, Goode PS, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. The effects of drug and behavior therapy on urgency and voiding frequency. Int Urogynecol J. 2010 Jun;21(6):711-9. doi: 10.1007/s00192-010-1100-x. Epub 2010 Feb 9.
PubMed 20143047
Burgio KL, Kraus SR, Menefee S, Borello-France D, Corton M, Johnson HW, Mallett V, Norton P, FitzGerald MP, Dandreo KJ, Richter HE, Rozanski T, Albo M, Zyczynski HM, Lemack GE, Chai TC, Khandwala S, Baker J, Brubaker L, Stoddard AM, Goode PS, Nielsen-Omeis B, Nager CW, Kenton K, Tennstedt SL, Kusek JW, Chang TD, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008 Aug 5;149(3):161-9. doi: 10.7326/0003-4819-149-3-200808050-00005.
PubMed 18678843
Fitzgerald MP, Lemack G, Wheeler T, Litman HJ; Urinary Incontinence Treatment Network. Nocturia, nocturnal incontinence prevalence, and response to anticholinergic and behavioral therapy. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1545-50. doi: 10.1007/s00192-008-0687-7. Epub 2008 Aug 14.
PubMed 18704249
Goode PS, Burgio KL, Kraus SR, Kenton K, Litman HJ, Richter HE; Urinary Incontinence Treatment Network. Correlates and predictors of patient satisfaction with drug therapy and combined drug therapy and behavioral training for urgency urinary incontinence in women. Int Urogynecol J. 2011 Mar;22(3):327-34. doi: 10.1007/s00192-010-1287-x. Epub 2010 Oct 13.
PubMed 20945064
Markland AD, Richter HE, Kenton KS, Wai C, Nager CW, Kraus SR, Xu Y, Tennstedt SL; Urinary Incontinence Treatment Network. Associated factors and the impact of fecal incontinence in women with urge urinary incontinence: from the Urinary Incontinence Treatment Network's Behavior Enhances Drug Reduction of Incontinence study. Am J Obstet Gynecol. 2009 Apr;200(4):424.e1-8. doi: 10.1016/j.ajog.2008.11.023. Epub 2009 Feb 6.
PubMed 19200939
Richter HE, Burgio KL, Chai TC, Kraus SR, Xu Y, Nyberg L, Brubaker L. Predictors of outcomes in the treatment of urge urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20(5):489-97. doi: 10.1007/s00192-009-0805-1. Epub 2009 Jan 30.
PubMed 19183825
Zimmern P, Litman HJ, Mueller E, Norton P, Goode P; Urinary Incontinence Treatment Network. Effect of fluid management on fluid intake and urge incontinence in a trial for overactive bladder in women. BJU Int. 2010 Jun;105(12):1680-5. doi: 10.1111/j.1464-410X.2009.09055.x. Epub 2009 Nov 13.
PubMed 19912207
Fitzgerald MP, Dubeau CE, Kraus SR, Johnson HW Jr, Rahn DD, Mallett V, Stoddard AM, Zyczynski HM; Urinary Incontinence Treatment Network. Patient expectations did not predict outcome of drug and behavioral treatment of urgency urinary incontinence. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):231-7. doi: 10.1097/SPV.0b013e31822dd10b.
PubMed 22453106
Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. doi: 10.1002/nau.21028. Epub 2011 May 11.
PubMed 21563210
Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598

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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Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Not yet recruiting
Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy
Urinary Incontinence (UI), Prostatectomy

All Urinary Incontinence (UI) trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavior Enhances Drug Reduction of Incontinence
ClinicalTrials.gov ID: NCT00090584
Acronym / sponsor ID: BE-DRI / BE-DRI (completed)
Conditions: Urinary Incontinence (UI)
Keywords: Urge urinary incontinence (UUI), Drug/Behavior treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: Carelon ResearchUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Aug 2004
Primary completion: Dec 2005 (actual)
Study completion: Aug 2006 (actual)
First posted: 31 Aug 2004 (estimated)
Results: Posted 17 Jun 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Combination therapy	Experimental	Drug: Tolterodine, Behavioral: Behavioral trainingWomen randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Drug therapy alone	Active comparator	Drug: TolterodineWomen assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female
Urge predominant incontinence
Incontinent > 3 mos
Available for 8 mos of followup

Key exclusion criteria (4 listed)

Pregnancy or < 6 mos post-partum
Hypersensitivity to drug (tolterodine)
Systemic disease that affects bladder function (e.g., Parkinson's disease, Multiple Sclerosis, spinal cord injury)
History of extensive behavior treatment

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
Tolterodine4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.	Drug	Combination therapy, Drug therapy alone
Behavioral trainingTraining in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.	Behavioural	Combination therapy

Primary outcome

Proportion of Women Who Meet Definition of Success
Time frame: 8 months
Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.

8 secondary outcomes

Change in Incontinence Episodes
Time frame: Baseline and 10 weeks
Change in Voids Per Day
Time frame: baseline and 10 weeks
Symptom Distress
Time frame: baseline, 10 weeks and 8 months
Symptom Bother
Time frame: baseline, 10 weeks and 8 months
Satisfaction
Time frame: 10 weeks
Satisfaction
Time frame: 8 months
Symptom Improvement
Time frame: 10 weeks
Symptom Improvement
Time frame: 8 months

Results and safety

Results posted to the registry on 17 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Therapy	154	139
Drug Therapy Alone	153	141

Primary outcome: Proportion of Women Who Meet Definition of Success

Time frame: 8 months. Number. Unit: participants

Measure	Combination Therapy n = 118	Drug Therapy Alone n = 119
Value	43	41

Combination Therapy vs Drug Therapy Alone: Difference in cumulative success rates: 0 (95% CI -0.12 to 0.12), p = 0.74, Log Rank

Population analysed: All women who completed the 8 months assessment or were known to return to drug use prior to that time.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored for adverse events throughout the study period (8 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Therapy	2 of 154 (1.3%)	2 of 154 (1.3%)	Not reported
Drug Therapy Alone	2 of 153 (1.3%)	1 of 153 (0.7%)	Not reported

Limitations and caveats (from the sponsor): Ony 68% of participants completed assigned treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16919506Urinary Incontinence Treatment Network (UITN). Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study. Contemp Clin Trials. 2007 Jan;28(1):48-58. doi: 10.1016/j.cct.2006.06.002. Epub 2006 Jun 18.
Background: PubMed 20671098Borello-France D, Burgio KL, Goode PS, Markland AD, Kenton K, Balasubramanyam A, Stoddard AM; Urinary Incontinence Treatment Network. Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. Phys Ther. 2010 Oct;90(10):1493-505. doi: 10.2522/ptj.20080387. Epub 2010 Jul 29.
Background: PubMed 21181960Brubaker L, Lukacz ES, Burgio K, Zimmern P, Norton P, Leng W, Johnson H, Kraus S, Stoddard A. Mixed incontinence: comparing definitions in non-surgical patients. Neurourol Urodyn. 2011 Jan;30(1):47-51. doi: 10.1002/nau.20922.
Background: PubMed 20143047Burgio KL, Kraus SR, Borello-France D, Chai TC, Kenton K, Goode PS, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. The effects of drug and behavior therapy on urgency and voiding frequency. Int Urogynecol J. 2010 Jun;21(6):711-9. doi: 10.1007/s00192-010-1100-x. Epub 2010 Feb 9.
Background: PubMed 18678843Burgio KL, Kraus SR, Menefee S, Borello-France D, Corton M, Johnson HW, Mallett V, Norton P, FitzGerald MP, Dandreo KJ, Richter HE, Rozanski T, Albo M, Zyczynski HM, Lemack GE, Chai TC, Khandwala S, Baker J, Brubaker L, Stoddard AM, Goode PS, Nielsen-Omeis B, Nager CW, Kenton K, Tennstedt SL, Kusek JW, Chang TD, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008 Aug 5;149(3):161-9. doi: 10.7326/0003-4819-149-3-200808050-00005.
Background: PubMed 18704249Fitzgerald MP, Lemack G, Wheeler T, Litman HJ; Urinary Incontinence Treatment Network. Nocturia, nocturnal incontinence prevalence, and response to anticholinergic and behavioral therapy. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1545-50. doi: 10.1007/s00192-008-0687-7. Epub 2008 Aug 14.
Background: PubMed 20945064Goode PS, Burgio KL, Kraus SR, Kenton K, Litman HJ, Richter HE; Urinary Incontinence Treatment Network. Correlates and predictors of patient satisfaction with drug therapy and combined drug therapy and behavioral training for urgency urinary incontinence in women. Int Urogynecol J. 2011 Mar;22(3):327-34. doi: 10.1007/s00192-010-1287-x. Epub 2010 Oct 13.
Background: PubMed 19200939Markland AD, Richter HE, Kenton KS, Wai C, Nager CW, Kraus SR, Xu Y, Tennstedt SL; Urinary Incontinence Treatment Network. Associated factors and the impact of fecal incontinence in women with urge urinary incontinence: from the Urinary Incontinence Treatment Network's Behavior Enhances Drug Reduction of Incontinence study. Am J Obstet Gynecol. 2009 Apr;200(4):424.e1-8. doi: 10.1016/j.ajog.2008.11.023. Epub 2009 Feb 6.
Background: PubMed 19183825Richter HE, Burgio KL, Chai TC, Kraus SR, Xu Y, Nyberg L, Brubaker L. Predictors of outcomes in the treatment of urge urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20(5):489-97. doi: 10.1007/s00192-009-0805-1. Epub 2009 Jan 30.
Background: PubMed 19912207Zimmern P, Litman HJ, Mueller E, Norton P, Goode P; Urinary Incontinence Treatment Network. Effect of fluid management on fluid intake and urge incontinence in a trial for overactive bladder in women. BJU Int. 2010 Jun;105(12):1680-5. doi: 10.1111/j.1464-410X.2009.09055.x. Epub 2009 Nov 13.
Background: PubMed 22453106Fitzgerald MP, Dubeau CE, Kraus SR, Johnson HW Jr, Rahn DD, Mallett V, Stoddard AM, Zyczynski HM; Urinary Incontinence Treatment Network. Patient expectations did not predict outcome of drug and behavioral treatment of urgency urinary incontinence. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):231-7. doi: 10.1097/SPV.0b013e31822dd10b.
Background: PubMed 21563210Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. doi: 10.1002/nau.21028. Epub 2011 May 11.
www.uitn.netLink 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.

William D Steers, M.D. study chair

University of Virginia

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

Questions about this trial

What is this clinical trial studying?

A study testing Tolterodine and Behavioral training in people with Urinary Incontinence (UI), run by Carelon Research at 9 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 4 inclusion and 4 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 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2013). 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?

Proportion of Women Who Meet Definition of Success (time frame: 8 months). 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 NCT00090584, which also lists 13 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 17 Jun 2013.