Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
NCT03391804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2020-12-30
Summary
Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
Conditions
- Enteric Hyperoxaluria
- Primary Hyperoxaluria
- Hyperoxalemia
Interventions
- DRUG
-
ALLN-177
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Sponsors & Collaborators
-
Allena Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
David Clark, MD · Allena Pharmaceuticals Inc
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-17
- Primary Completion
- 2019-12-13
- Completion
- 2019-12-13
- FDA Drug
- Yes
Countries
- United States
- Germany
- United Kingdom
Study Locations
More Related Trials
-
Effect of 7 Days of Dosing With a 10 mg Rectal Suppository of NRL001in Patients With Faecal Incontinence
NCT01175941 ·Status: COMPLETED ·Phase: PHASE1
-
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
NCT01262391 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
NCT04641975 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
NCT01157377 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3
NCT06465472 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Study Evaluating Patients With Cystinuria
NCT04137978 ·Status: WITHDRAWN ·Phase: PHASE2/PHASE3
-
A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients
NCT00840645 ·Status: COMPLETED ·Phase: PHASE3
-
Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
NCT00650481 ·Status: COMPLETED ·Phase: PHASE1
-
Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
NCT00648843 ·Status: COMPLETED ·Phase: PHASE1
-
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
NCT00171145 ·Status: COMPLETED ·Phase: PHASE3
-
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
NCT00439192 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy Study of VA106483 in Males With Nocturia.
NCT01038843 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
NCT00171184 ·Status: COMPLETED ·Phase: PHASE4
-
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
NCT00340704 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication
NCT01317810 ·Status: WITHDRAWN
-
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
NCT00212706 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
NCT01655069 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents
NCT01210859 ·Status: WITHDRAWN
-
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
NCT00712322 ·Status: TERMINATED ·Phase: PHASE2
-
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
NCT00350636 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
NCT00337558 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
NCT00699049 ·Status: COMPLETED ·Phase: PHASE4
-
VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate
NCT01777217 ·Status: TERMINATED ·Phase: PHASE4
-
Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
NCT01799902 ·Status: COMPLETED
-
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
NCT01257737 ·Status: COMPLETED ·Phase: PHASE4