Overactive BladderPhase 2NCT03475706
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
A Phase 2 study testing Solabegron immediate release tablets, low dose and Solabegron immediate release tablets, high dose in people with Overactive Bladder, run by Velicept Therapeutics, Inc. at 86 sites in United States.
Trial summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solabegron immediate release tablets, low dose and Solabegron immediate release tablets, high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 86 sitesUnited States
- Study dates
- 19 Feb 2018to 30 Jan 2019
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, and urgency urinary incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).
Who cannot join
- Subjects must have no history of pelvic or bladder disease, e.g., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time.
- Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
- Cardiac conditions: prior cardiovascular events or procedures within 6 months of screening; congestive heart failure; abnormal ECG findings, including ECG QT correction interval (QTc) > 470 msec at the Screening Visit; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥100mmHg, or heart rate > 100 beats per minute.
- Abnormal tests of liver function
- History of prior infection due to HIV or hepatitis B or hepatitis C virus
- Allergy or hypersensitivity to solabegron or mirabegron
Show all 9Show fewer
- Women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant
- Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the Screening Visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to Screening Visit.
- Inability to read, understand, or complete study-related materials.
Trial locations and contacts
86 sites in 1 country.
86 sites in 1 country
United States86 sites
Velicept Investigative Site - Albuquerque
Albuquerque, New Mexico, 87102
Velicept Investigative Site - Anaheim
Anaheim, California, 92801
Velicept Investigative Site - Arcadia
Arcadia, California, 91007
Velicept Investigative Site - Austin
Austin, Texas, 78735
Velicept Investigative Site - Beaumont
Beaumont, Texas, 77702
Velicept Investigative Site - Birmingham
Birmingham, Alabama, 35205
Velicept Investigative Site - Blackfoot
Blackfoot, Idaho, 83221
Velicept Investigative Site - Boston
Boston, Massachusetts, 02131
Velicept Investigative Site - Brick
Brick, New Jersey, 08724
Velicept Investigative Site - Canoga Park
Canoga Park, California, 91303
Velicept Investigative Site - Charlotte
Charlotte, North Carolina, 28203
Velicept Investigative Site - Cincinnati
Cincinnati, Ohio, 45236
Velicept Investigative Site - Clearwater
Clearwater, Florida, 33761
Velicept Investigative Site - Cleveland
Cleveland, Ohio, 44122
Velicept Investigative Site - Clinton
Clinton, Utah, 84015
Velicept Investigative Site - Columbus
Columbus, Ohio, 43123
Velicept Investigative Site - Deland
DeLand, Florida, 32720
Velicept Investigative Site - Denver
Denver, Colorado, 80209
Velicept Investigative Site - Doral
Doral, Florida, 33166
Velicept Investigative Site - Elwood
Elwood, Indiana, 46036
Velicept Investigative Site - Evansville
Evansville, Indiana, 47714
Velicept Investigative Site - Gulf Shores
Gulf Shores, Alabama, 36542
Velicept Investigative Site - Huntington Beach
Huntington Beach, California, 92647
Velicept Investigative Site - Jackson
Jackson, Tennessee, 38305
Velicept Investigative Site - Jupiter
Jupiter, Florida, 33458
Velicept Investigative Site - Kalamazoo
Kalamazoo, Michigan, 49009
Velicept Investigative Site - Kenosha
Kenosha, Wisconsin, 53142
Velicept Investigative Site - Knoxville
Knoxville, Tennessee, 37920
Velicept Investigative Site - Lake City
Lake City, Florida, 32055
Velicept Investigative Site - Lampasas
Lampasas, Texas, 76550
Velicept Investigative Site - Las Vegas
Las Vegas, Nevada, 89119
Velicept Investigative Site - Little Rock
Little Rock, Arkansas, 72212
Velicept Investigative Site - Longview
Longview, Texas, 80209
Velicept Investigative Site - Los Alamitos
Los Alamitos, California, 90720
Velicept Investigative Site - Los Angeles
Los Angeles, California, 90017
Velicept Investigative Site - Louisville
Louisville, Kentucky, 40291
Velicept Investigative Site - Marietta
Marietta, Georgia, 30060
Velicept Investigative Site - Marion
Marion, Ohio, 43302
Velicept Investigative Site - Meridian
Meridian, Idaho, 83642
Velicept Investigative Site - Metairie
Metairie, Louisiana, 70001
Velicept Investigative Site - Miami
Miami, Florida, 33135
Velicept Investigative Site - Miami
Miami, Florida, 33176
Velicept Investigative Site - Miami
Miami, Florida, 33186
Velicept Investigative Site - Middleburg Heights
Middleburg Heights, Ohio, 44130
Velicept Investigative Site - Mobile
Mobile, Alabama, 36608
Velicept Investigative Site - Mt. Pleasant
Mt. Pleasant, South Carolina, 29464
Velicept Investigative Site - Myrtle Beach
Myrtle Beach, South Carolina, 29572
Velicept Investigative Site - Nashville
Nashville, Tennessee, 37203
Velicept Investigative Site - New Bedford
New Bedford, Massachusetts, 02740
Velicept Investigative Site - New Orleans
New Orleans, Louisiana, 70115
Velicept Investigative Site - New York
New York, New York, 10016
Velicept Investigative Site - Newport News
Newport News, Virginia, 23606
Velicept Investigative Site - Newton
Newton, Kansas, 67114
Velicept Investigative Site - Norco
Norco, California, 92860
Velicept Investigative Site - Norfolk
Norfolk, Virginia, 23507
Velicept Investigative Site - North Attleborro
North Attleboro, Massachusetts, 02760
Velicept Investigative Site - Omaha
Omaha, Nebraska, 68114
Velicept Investigative Site - Ponte Vedra
Ponte Vedra, Florida, 32081
Velicept Investigative Site - Port St Lucie
Port Saint Lucie, Florida, 34952
Velicept Investigative Site - Sacramento
Sacramento, California, 95821
Velicept Investigative Site - Salt Lake City
Salt Lake City, Utah, 84107
Velicept Investigative Site - Salt Lake City
Salt Lake City, Utah, 84124
Velicept Investigative Site - San Antonio
San Antonio, Texas, 78209
Velicept Investigative Site - San Antonio
San Antonio, Texas, 78229
Velicept Investigative Site - San Antonio
San Antonio, Texas, 78249
Velicept Investigative Site - San Diego
San Diego, California, 92103
Velicept Investigative Site - San Diego
San Diego, California, 92123
Velicept Investigative Site - San Marcos
San Marcos, California, 92078
Velicept Investigative Site - Shreveport
Shreveport, Louisiana, 71106
Velicept Investigative Site - St. Louis
St Louis, Missouri, 63141
Velicept Investigative Site - St. George
St. George, Utah, 84790
Velicept Investigative Site - Tacoma
Tacoma, Washington, 98405
Velicept Investigative Site - Tempe
Tempe, Arizona, 85283
Velicept Investigative Site - Thousand Oaks
Thousand Oaks, California, 91360
Velicept Investigative Site - Tucson
Tucson, Arizona, 87504
Velicept Investigative Site - Vorhees
Voorhees Township, New Jersey, 08043
Velicept Investigative Site - Warwick
Warwick, Rhode Island, 02818
Velicept Investigative Site - Waterbury
Waterbury, Connecticut, 06708
Velicept Investigative Site - Watertown
Watertown, Massachusetts, 02472
Velicept Investigative Site - Wauconda
Wauconda, Illinois, 60084
Velicept Investigative Site - West Jordan
West Jordan, Utah, 84088
Velicept Investigative Site - West Palm Beach
West Palm Beach, Florida, 33409
Velicept Investigative Site - Williamsville
Williamsville, New York, 14221
Velicept Investigative Site - Wilmington
Wilmington, North Carolina, 28401
Velicept Investigative Site - Winston-Salem
Winston-Salem, North Carolina, 27103
Velicept Investigative Site - Winter Haven
Winter Haven, Florida, 33880
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Immediate Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.
- Conditions
- Overactive Bladder
- Being tested
- Solabegron immediate release tablets, low dose, Solabegron immediate release tablets, high dose, Matching Placebo
- Keywords
- overactive bladder, urinary conditions, urgency urinary incontinence, urgency, micturitions
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solabegron immediate release tablets, low doseDrug
twice daily for 12 weeks.
Solabegron immediate release tablets, high doseDrug
twice daily for 12 weeks.
Matching PlaceboDrug
twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Solabegron immediate release tablets low dose | Experimental | Not described Receives: Drug: Solabegron immediate release tablets, low dose |
| Solabegron immediate release tablets high dose | Experimental | Not described Receives: Drug: Solabegron immediate release tablets, high dose |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in mean number of micturitions per 24h at Week 12
Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.
Measured: Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).
Secondary outcomes (18)
Urinary Incontinence (1)
Change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (2)
Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4 and 8
Urinary Incontinence (3)
Proportion of subjects with no episodes of urgency urinary incontinence per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (4)
Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (5)
Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (1)
Change from Baseline in mean number of micturitions per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4 and 8
Micturitions (2)
Percentage change from Baseline in mean number of micturitions per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (3)
Percentage of subjects with <8 micturitions per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (4)
Change from Baseline in mean number of nocturnal voids per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (1)
Change from Baseline in average void volume over 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (2)
Percentage change from Baseline in average void volume over 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (3)
Change from Baseline in maximum individual void volume over 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (4)
Percentage change from Baseline in maximum individual void volume over 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (1)
Proportion of subjects with urges with a mean grade of 3 or 4 per 24h.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (2)
Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (1)
Patient Perception of Bladder Condition
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (2)
Change from Baseline in Symptom Bother Score (OAB-q short form).
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (3)
Change from Baseline in health-related quality of life (OAB-q short form).
Measured: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start19 Feb 2018
- Primary completion24 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Eligible female subjects (N=406) with symptoms of overactive bladder for at least 6 months will enter a 14-day single-blind Run-in Period. Subjects (N=375) who meet prespecified criteria based on data entered into an electronic diary over 3 days will be randomized 1:1:1 (125 subjects per arm) to receive solabegron immediate release tablets, low dose or high dose, or matching placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Velicept Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475706
- Sponsor's protocol ID
- VEL-2002
- Status last verified
- Jan 2019
- First submitted
- 12 Mar 2018
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohlstein EH, von Keitz A, Michel MC. A multicenter, double-blind, randomized, placebo-controlled trial of the beta3-adrenoceptor agonist solabegron for overactive bladder. Eur Urol. 2012 Nov;62(5):834-40. doi: 10.1016/j.eururo.2012.05.053. Epub 2012 Jun 5.
PubMed 22695239
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Immediate Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects
- ClinicalTrials.gov ID
- NCT03475706
- Acronym / sponsor ID
- VEL-2002
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, urinary conditions, urgency urinary incontinence, urgency, micturitions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Velicept Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 23 Mar 2018 (actual)
- 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.
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Eligible female subjects (N=406) with symptoms of overactive bladder for at least 6 months will enter a 14-day single-blind Run-in Period. Subjects (N=375) who meet prespecified criteria based on data entered into an electronic diary over 3 days will be randomized 1:1:1 (125 subjects per arm) to receive solabegron immediate release tablets, low dose or high dose, or matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Solabegron immediate release tablets low dose | Experimental | Drug: Solabegron immediate release tablets, low dose |
| Solabegron immediate release tablets high dose | Experimental | Drug: Solabegron immediate release tablets, high dose |
| Placebo Comparator | Placebo comparator | Drug: Matching Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, and urgency urinary incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).
Key exclusion criteria (9 listed)
- Subjects must have no history of pelvic or bladder disease, e.g., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time.
- Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
- Cardiac conditions: prior cardiovascular events or procedures within 6 months of screening; congestive heart failure; abnormal ECG findings, including ECG QT correction interval (QTc) > 470 msec at the Screening Visit; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥100mmHg, or heart rate > 100 beats per minute.
- Abnormal tests of liver function
- History of prior infection due to HIV or hepatitis B or hepatitis C virus
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 |
|---|---|---|
| Solabegron immediate release tablets, low dosetwice daily for 12 weeks. | Drug | Solabegron immediate release tablets low dose |
| Solabegron immediate release tablets, high dosetwice daily for 12 weeks. | Drug | Solabegron immediate release tablets high dose |
| Matching Placebotwice daily for 12 weeks. | Drug | Placebo Comparator |
Primary outcome
Change from Baseline in mean number of micturitions per 24h at Week 12
Time frame: Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).
Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.
18 secondary outcomes
Urinary Incontinence (1)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (2)
Time frame: Prior to Randomization (Baseline) and at Weeks 4 and 8
Urinary Incontinence (3)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (4)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (5)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (1)
Time frame: Prior to Randomization (Baseline) and at Weeks 4 and 8
Micturitions (2)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (3)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (4)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (1)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (2)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (3)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (4)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (1)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (2)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (1)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (2)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (3)
Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 22695239Ohlstein EH, von Keitz A, Michel MC. A multicenter, double-blind, randomized, placebo-controlled trial of the beta3-adrenoceptor agonist solabegron for overactive bladder. Eur Urol. 2012 Nov;62(5):834-40. doi: 10.1016/j.eururo.2012.05.053. Epub 2012 Jun 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
86 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 Solabegron immediate release tablets, low dose and Solabegron immediate release tablets, high dose in people with Overactive Bladder, run by Velicept Therapeutics, Inc. at 86 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 9 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in mean number of micturitions per 24h at Week 12 (time frame: Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).). 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 NCT03475706, which also lists 1 linked publication.
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 2 Mar 2020.