NocturiaPhase 4NCT01018225
Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness
A Phase 4 study testing darifenacin in people with Nocturia, run by Cognitive Research Corporation.
Trial summary
The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Nocturia
- What is being tested?
- darifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jul 2010
- Phase
- Phase 4
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be aged 21-70, inclusive.
- Subject mush have given written, personally signed and dated informed consent.
- Subject must be diagnosed with overactive bladder.
- Subject must have a nocturia frequency of greater than or equal to 3 episodes a night.
- Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements.
- Subject understands and is able, will a nd and likely to fully comply with study procedures and restrictions.
Who cannot join
- Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
- The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components).
- The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions.
- Subject is taking another drug which is considered to have significant anticholinergic activity.
- Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs.
- Subject has moderate to severe obstructive sleep apnea (Apnea/Hypopnea Index ≥ 15)
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- Subject has a medical condition other than OAB that is the most likely cause of the subject's nocturia (e.g., primary sleep disorder, polydipsia, polyuria).
- Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
- The female subject is pregnant or lactating.
- Subjects with a urine drug screen positive for stimulants, barbiturates, hallucinogens, opiates, cocaine, cannabis, or amphetamines
About this study
The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia.
- Conditions
- Nocturia
- Being tested
- darifenacin, Placebo
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darifenacinDrug
Also called Enablex
7.5 or 15 mg darifenacin, once a day for 6 weeks
PlaceboDrug
Placebo pill, once a day, for six weeks
| Study group | Role | What they receive |
|---|---|---|
| darifenacin | Experimental | Not described Receives: Drug: darifenacin |
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Study completionJul 2010 (estimated)
Why it stopped: Study was cancelled due to lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies 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 4
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognitive Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018225
- Sponsor's protocol ID
- CRC090001
- Status last verified
- Apr 2016
- First submitted
- 20 Nov 2009
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness
- ClinicalTrials.gov ID
- NCT01018225
- Acronym / sponsor ID
- CRC090001
- Conditions
- Nocturia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled due to lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cognitive Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Nov 2009
- Study completion
- Jul 2010 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| darifenacin | Experimental | Drug: darifenacin |
| Sugar Pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be aged 21-70, inclusive.
- Subject mush have given written, personally signed and dated informed consent.
- Subject must be diagnosed with overactive bladder.
- Subject must have a nocturia frequency of greater than or equal to 3 episodes a night.
- Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements.
Key exclusion criteria (10 listed)
- Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
- The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components).
- The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions.
- Subject is taking another drug which is considered to have significant anticholinergic activity.
- Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs.
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 |
|---|---|---|
| darifenacinAlso: Enablex7.5 or 15 mg darifenacin, once a day for 6 weeks | Drug | darifenacin |
| PlaceboPlacebo pill, once a day, for six weeks | Drug | Sugar Pill |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing darifenacin in people with Nocturia, run by Cognitive Research Corporation.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 13 Apr 2016.