Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome

NCT01657409 | Completed Phase 2

• 1 other identifier: TCGHUROL003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urge urinary incontinence (UUI) that may affect the patients' quality of life. Current medical treatments are usually unsuccessful in completely eradicating urgency sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of neurotransmitters from sensory nerve endings and effectively modulates the inflammatory process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results were achieved with intravesical BoNT-A injection, which increased bladder capacity and decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also improved significantly. However, post void residual (PVR) volume increased significantly and some patients required clean intermittent catheterization (CIC) to evacuate the PVR. Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore, adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help to maintain success rates.

Conditions

Overactive Bladder

Keywords

botulinum toxin; detrusor overactivity

Outcome Measures

Primary Outcomes (1)

• Global response assessment (GRA) of satisfaction by the patient

  GRA (-3, -2, -1, 0, +1, +2, +3) of satisfaction by the patient * GRA≥+1: Respond * GRA≤0: Non-respond

  2 weeks after initial treatment

Secondary Outcomes (1)

• Voiding and urodynamic parameters

  2 weeks after the initial treatment day

Study Arms (3)

BoNT-A (10 injection)

EXPERIMENTAL

100 U in 10ml, 1.0ml for each injection, totally 10 injections at bladder body

Drug: BoNT-A (10 injection)

BoNT-A (20 injections)

EXPERIMENTAL

100 U in 10ml, 0.5ml for each injection, totally 20 injections at bladder body

Drug: BoNT-A (20 injection)

BoNT-A (40 injections)

EXPERIMENTAL

100 U in 10ml, 0.25ml for each injection, totally 40 injections at bladder body

Drug: BoNT-A (40 injection)

Interventions

BoNT-A (10 injection) DRUG

BoNT-A 100 U 10 injections

Also known as: Botulinum Toxin A (Botox)

BoNT-A (10 injection)

BoNT-A (20 injection) DRUG

BoNT-A 100 U 20 injections

Also known as: Botulinum Toxin A (Botox)

BoNT-A (20 injections)

BoNT-A (40 injection) DRUG

BoNT-A 100 U 40 injections

Also known as: Botulinum Toxin A (Botox)

BoNT-A (40 injections)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms
• Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
• Patients with bladder outlet obstruction on enrollment
• Patients with postvoid residual \> 150ml
• Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
• Patients have laboratory abnormalities at screening including:
• Alanine aminotransferase (ALT)\> 3 x upper limit of normal range
• Aspartate aminotransferase (AST)\> 3 x upper limit of normal range
• Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
• Patients with any contraindication to be urethral catheterization during treatment
• Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
• Myasthenia gravis, Eaton Lambert syndrome.
• Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial Patients participated investigational drug trial within 1 month before entering this study

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

Related Publications (55)

• Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90.

  PMID: 11183901 BACKGROUND

• Irwin DE, Milsom I, Kopp Z, Abrams P, Cardozo L. Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int. 2006 Jan;97(1):96-100. doi: 10.1111/j.1464-410X.2005.05889.x.

  PMID: 16336336 BACKGROUND

• Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.

  PMID: 11412210 BACKGROUND

• Chen GD, Lin TL, Hu SW, Chen YC, Lin LY. Prevalence and correlation of urinary incontinence and overactive bladder in Taiwanese women. Neurourol Urodyn. 2003;22(2):109-17. doi: 10.1002/nau.10010.

  PMID: 12579627 BACKGROUND

• Homma Y, Yamaguchi O, Hayashi K; Neurogenic Bladder Society Committee. An epidemiological survey of overactive bladder symptoms in Japan. BJU Int. 2005 Dec;96(9):1314-8. doi: 10.1111/j.1464-410X.2005.05835.x.

  PMID: 16287452 BACKGROUND

• Kullmann FA, Artim DE, Birder LA, de Groat WC. Activation of muscarinic receptors in rat bladder sensory pathways alters reflex bladder activity. J Neurosci. 2008 Feb 20;28(8):1977-87. doi: 10.1523/JNEUROSCI.4694-07.2008.

  PMID: 18287514 BACKGROUND

• Mukerji G, Yiangou Y, Grogono J, Underwood J, Agarwal SK, Khullar V, Anand P. Localization of M2 and M3 muscarinic receptors in human bladder disorders and their clinical correlations. J Urol. 2006 Jul;176(1):367-73. doi: 10.1016/S0022-5347(06)00563-5.

  PMID: 16753445 BACKGROUND

• Ouslander JG. Management of overactive bladder. N Engl J Med. 2004 Feb 19;350(8):786-99. doi: 10.1056/NEJMra032662. No abstract available.

  PMID: 14973214 BACKGROUND

• Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. Eur J Phys Rehabil Med. 2008 Mar;44(1):47-63.

  PMID: 18385628 BACKGROUND

• Simpson LL. Kinetic studies on the interaction between botulinum toxin type A and the cholinergic neuromuscular junction. J Pharmacol Exp Ther. 1980 Jan;212(1):16-21.

  PMID: 6243359 BACKGROUND

• Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54.

  PMID: 16094018 BACKGROUND

• Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. doi: 10.1046/j.1526-4610.43.7s.3.x.

  PMID: 12887389 BACKGROUND

• Yiangou Y, Facer P, Ford A, Brady C, Wiseman O, Fowler CJ, Anand P. Capsaicin receptor VR1 and ATP-gated ion channel P2X3 in human urinary bladder. BJU Int. 2001 Jun;87(9):774-9. doi: 10.1046/j.1464-410x.2001.02190.x.

  PMID: 11412212 BACKGROUND

• Avelino A, Cruz F. TRPV1 (vanilloid receptor) in the urinary tract: expression, function and clinical applications. Naunyn Schmiedebergs Arch Pharmacol. 2006 Jul;373(4):287-99. doi: 10.1007/s00210-006-0073-2. Epub 2006 May 24.

  PMID: 16721555 BACKGROUND

• Popat R, Apostolidis A, Kalsi V, Gonzales G, Fowler CJ, Dasgupta P. A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. J Urol. 2005 Sep;174(3):984-9. doi: 10.1097/01.ju.0000169480.43557.31.

  PMID: 16094019 BACKGROUND

• Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007.

  PMID: 15134967 BACKGROUND

• Sahai A, Khan MS, Dasgupta P. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial. J Urol. 2007 Jun;177(6):2231-6. doi: 10.1016/j.juro.2007.01.130.

  PMID: 17509328 BACKGROUND

• Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.

  PMID: 18499184 BACKGROUND

• Reitz A, Stohrer M, Kramer G, Del Popolo G, Chartier-Kastler E, Pannek J, Burgdorfer H, Gocking K, Madersbacher H, Schumacher S, Richter R, von Tobel J, Schurch B. European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol. 2004 Apr;45(4):510-5. doi: 10.1016/j.eururo.2003.12.004.

  PMID: 15041117 BACKGROUND

• Kessler TM, Danuser H, Schumacher M, Studer UE, Burkhard FC. Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity? Neurourol Urodyn. 2005;24(3):231-6. doi: 10.1002/nau.20105.

  PMID: 15747344 BACKGROUND

• Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.

  PMID: 16153215 BACKGROUND

• Schulte-Baukloh H, Weiss C, Stolze T, Sturzebecher B, Knispel HH. Botulinum-A toxin for treatment of overactive bladder without detrusor overactivity: urodynamic outcome and patient satisfaction. Urology. 2005 Jul;66(1):82-7. doi: 10.1016/j.urology.2005.01.036.

  PMID: 15992872 BACKGROUND

• Kuo HC. Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Urology. 2005 Jul;66(1):94-8. doi: 10.1016/j.urology.2005.02.002.

  PMID: 15992869 BACKGROUND

• Ghei M, Maraj BH, Miller R, Nathan S, O'Sullivan C, Fowler CJ, Shah PJ, Malone-Lee J. Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. J Urol. 2005 Nov;174(5):1873-7; discussion 1877. doi: 10.1097/01.ju.0000177477.83991.88.

  PMID: 16217327 BACKGROUND

• Sahai A, Sangster P, Kalsi V, Khan MS, Fowler CJ, Dasgupta P. Assessment of urodynamic and detrusor contractility variables in patients with overactive bladder syndrome treated with botulinum toxin-A: is incomplete bladder emptying predictable? BJU Int. 2009 Mar;103(5):630-4. doi: 10.1111/j.1464-410X.2008.08076.x. Epub 2008 Oct 16.

  PMID: 18990156 BACKGROUND

• White WM, Pickens RB, Doggweiler R, Klein FA. Short-term efficacy of botulinum toxin a for refractory overactive bladder in the elderly population. J Urol. 2008 Dec;180(6):2522-6. doi: 10.1016/j.juro.2008.08.030. Epub 2008 Oct 19.

  PMID: 18930481 BACKGROUND

• Brady CM, Apostolidis AN, Harper M, Yiangou Y, Beckett A, Jacques TS, Freeman A, Scaravilli F, Fowler CJ, Anand P. Parallel changes in bladder suburothelial vanilloid receptor TRPV1 and pan-neuronal marker PGP9.5 immunoreactivity in patients with neurogenic detrusor overactivity after intravesical resiniferatoxin treatment. BJU Int. 2004 Apr;93(6):770-6. doi: 10.1111/j.1464-410X.2003.04722.x.

  PMID: 15049988 BACKGROUND

• Brady CM, Apostolidis A, Yiangou Y, Baecker PA, Ford AP, Freeman A, Jacques TS, Fowler CJ, Anand P. P2X3-immunoreactive nerve fibres in neurogenic detrusor overactivity and the effect of intravesical resiniferatoxin. Eur Urol. 2004 Aug;46(2):247-53. doi: 10.1016/j.eururo.2003.12.017.

  PMID: 15245821 BACKGROUND

• Smet PJ, Moore KH, Jonavicius J. Distribution and colocalization of calcitonin gene-related peptide, tachykinins, and vasoactive intestinal peptide in normal and idiopathic unstable human urinary bladder. Lab Invest. 1997 Jul;77(1):37-49.

  PMID: 9251677 BACKGROUND

• Yoshida M, Miyamae K, Iwashita H, Otani M, Inadome A. Management of detrusor dysfunction in the elderly: changes in acetylcholine and adenosine triphosphate release during aging. Urology. 2004 Mar;63(3 Suppl 1):17-23. doi: 10.1016/j.urology.2003.11.003.

  PMID: 15013648 BACKGROUND

• Apostolidis A, Brady CM, Yiangou Y, Davis J, Fowler CJ, Anand P. Capsaicin receptor TRPV1 in urothelium of neurogenic human bladders and effect of intravesical resiniferatoxin. Urology. 2005 Feb;65(2):400-5. doi: 10.1016/j.urology.2004.10.007.

  PMID: 15708075 BACKGROUND

• Wiseman OJ, Fowler CJ, Landon DN. The role of the human bladder lamina propria myofibroblast. BJU Int. 2003 Jan;91(1):89-93. doi: 10.1046/j.1464-410x.2003.03802.x.

  PMID: 12614258 BACKGROUND

• Sui GP, Rothery S, Dupont E, Fry CH, Severs NJ. Gap junctions and connexin expression in human suburothelial interstitial cells. BJU Int. 2002 Jul;90(1):118-29. doi: 10.1046/j.1464-410x.2002.02834.x.

  PMID: 12081783 BACKGROUND

• Apostolidis A, Dasgupta P, Fowler CJ. Proposed mechanism for the efficacy of injected botulinum toxin in the treatment of human detrusor overactivity. Eur Urol. 2006 Apr;49(4):644-50. doi: 10.1016/j.eururo.2005.12.010. Epub 2006 Jan 4.

  PMID: 16426734 BACKGROUND

• Tyagi P, Wu PC, Chancellor M, Yoshimura N, Huang L. Recent advances in intravesical drug/gene delivery. Mol Pharm. 2006 Jul-Aug;3(4):369-79. doi: 10.1021/mp060001j.

  PMID: 16889430 BACKGROUND

• Giannantoni A, Di Stasi SM, Chancellor MB, Costantini E, Porena M. New frontiers in intravesical therapies and drug delivery. Eur Urol. 2006 Dec;50(6):1183-93; discussion 1193. doi: 10.1016/j.eururo.2006.08.025. Epub 2006 Aug 30.

  PMID: 16963179 BACKGROUND

• Giannantoni A, Porena M, Costantini E, Zucchi A, Mearini L, Mearini E. Botulinum A toxin intravesical injection in patients with painful bladder syndrome: 1-year followup. J Urol. 2008 Mar;179(3):1031-4. doi: 10.1016/j.juro.2007.10.032. Epub 2008 Jan 18.

  PMID: 18206941 BACKGROUND

• Kuo HC, Liu HT, Yang WC. Therapeutic effect of multiple resiniferatoxin intravesical instillations in patients with refractory detrusor overactivity: a randomized, double-blind, placebo controlled study. J Urol. 2006 Aug;176(2):641-5. doi: 10.1016/j.juro.2006.03.087.

  PMID: 16813911 BACKGROUND

• Birder LA. More than just a barrier: urothelium as a drug target for urinary bladder pain. Am J Physiol Renal Physiol. 2005 Sep;289(3):F489-95. doi: 10.1152/ajprenal.00467.2004.

  PMID: 16093424 BACKGROUND

• Chuang YC, Yoshimura N, Huang CC, Chiang PH, Chancellor MB. Intravesical botulinum toxin a administration produces analgesia against acetic acid induced bladder pain responses in rats. J Urol. 2004 Oct;172(4 Pt 1):1529-32. doi: 10.1097/01.ju.0000137844.77524.97.

  PMID: 15371885 BACKGROUND

• Liu HT, Chancellor MB, Kuo HC. Urinary nerve growth factor levels are elevated in patients with detrusor overactivity and decreased in responders to detrusor botulinum toxin-A injection. Eur Urol. 2009 Oct;56(4):700-6. doi: 10.1016/j.eururo.2008.04.037. Epub 2008 Apr 30.

  PMID: 18472208 BACKGROUND

• Atiemo H, Wynes J, Chuo J, Nipkow L, Sklar GN, Chai TC. Effect of botulinum toxin on detrusor overactivity induced by intravesical adenosine triphosphate and capsaicin in a rat model. Urology. 2005 Mar;65(3):622-6. doi: 10.1016/j.urology.2004.10.057.

  PMID: 15780404 BACKGROUND

• Crowley SL, Worchel FF, Ash MJ. Self-report, peer-report, and teacher-report measures of childhood depression: an analysis by item. J Pers Assess. 1992 Aug;59(1):189-203. doi: 10.1207/s15327752jpa5901_16.

  PMID: 1512677 BACKGROUND

• Vemulakonda VM, Somogyi GT, Kiss S, Salas NA, Boone TB, Smith CP. Inhibitory effect of intravesically applied botulinum toxin A in chronic bladder inflammation. J Urol. 2005 Feb;173(2):621-4. doi: 10.1097/01.ju.0000143189.19835.f3.

  PMID: 15643276 BACKGROUND

• Fraser MO, Chuang YC, Tyagi P, Yokoyama T, Yoshimura N, Huang L, De Groat WC, Chancellor MB. Intravesical liposome administration--a novel treatment for hyperactive bladder in the rat. Urology. 2003 Mar;61(3):656-63. doi: 10.1016/s0090-4295(02)02281-1.

  PMID: 12639679 BACKGROUND

• Chuang YC, Tyagi P, Huang CC, Yoshimura N, Wu M, Kaufman J, Chancellor MB. Urodynamic and immunohistochemical evaluation of intravesical botulinum toxin A delivery using liposomes. J Urol. 2009 Aug;182(2):786-92. doi: 10.1016/j.juro.2009.03.083. Epub 2009 Jun 18.

  PMID: 19539320 BACKGROUND

• Reimer K, Fleischer W, Brogmann B, Schreier H, Burkhard P, Lanzendorfer A, Gumbel H, Hoekstra H, Behrens-Baumann W. Povidone-iodine liposomes--an overview. Dermatology. 1997;195 Suppl 2:93-9. doi: 10.1159/000246039.

  PMID: 9403264 BACKGROUND

• Egerdie RB, Reid G, Trachtenberg J. The effect of liposome encapsulated antineoplastic agents on transitional cell carcinoma in tissue culture. J Urol. 1989 Aug;142(2 Pt 1):390-8. doi: 10.1016/s0022-5347(17)38771-2.

  PMID: 2501520 BACKGROUND

• Tyagi P, Chancellor MB, Li Z, De Groat WC, Yoshimura N, Fraser MO, Huang L. Urodynamic and immunohistochemical evaluation of intravesical capsaicin delivery using thermosensitive hydrogel and liposomes. J Urol. 2004 Jan;171(1):483-9. doi: 10.1097/01.ju.0000102360.11785.d7.

  PMID: 14665960 BACKGROUND

• Chuang YC, Lee WC, Lee WC, Chiang PH. Intravesical liposome versus oral pentosan polysulfate for interstitial cystitis/painful bladder syndrome. J Urol. 2009 Oct;182(4):1393-400. doi: 10.1016/j.juro.2009.06.024. Epub 2009 Aug 15.

  PMID: 19683290 BACKGROUND

• Liu HT, Kuo HC. Intravesical botulinum toxin A injections plus hydrodistension can reduce nerve growth factor production and control bladder pain in interstitial cystitis. Urology. 2007 Sep;70(3):463-8. doi: 10.1016/j.urology.2007.04.038.

  PMID: 17905097 BACKGROUND

• Truschel ST, Wang E, Ruiz WG, Leung SM, Rojas R, Lavelle J, Zeidel M, Stoffer D, Apodaca G. Stretch-regulated exocytosis/endocytosis in bladder umbrella cells. Mol Biol Cell. 2002 Mar;13(3):830-46. doi: 10.1091/mbc.01-09-0435.

  PMID: 11907265 BACKGROUND

• Wang E, Truschel S, Apodaca G. Analysis of hydrostatic pressure-induced changes in umbrella cell surface area. Methods. 2003 Jul;30(3):207-17. doi: 10.1016/s1046-2023(03)00027-6.

  PMID: 12798135 BACKGROUND

• Cui M, Aoki KR. Botulinum toxin type A (BTX-A) reduces inflammatory pain in the rat formalin model. Cephalalgia 20:414-8, 2000.

  BACKGROUND

• Hsiao SM, Lin HH, Kuo HC. Factors Associated with Therapeutic Efficacy of Intravesical OnabotulinumtoxinA Injection for Overactive Bladder Syndrome. PLoS One. 2016 Jan 29;11(1):e0147137. doi: 10.1371/journal.pone.0147137. eCollection 2016.

  PMID: 26824901 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hann-Chorng Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants did not aware how many injections were performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Urology

Model Details: Patients were randomized to receive different injection number of onabotulinumtoxinA

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

TW (1)