NocturiaPhase 2NOCNCT01694498

Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men

A Phase 2 study testing A: Desmopressin 25 µg and B. Desmopressin 50 µg in people with Nocturia, run by Ferring Pharmaceuticals at 35 sites in Japan.

Completed

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

Official record

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Trial summary

The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult men during 12 weeks treatment Read more about this study

Who is it for?: Ages 20 years and older, men only
Conditions the study is for: Nocturia
What is being tested?: A: Desmopressin 25 µg and B. Desmopressin 50 µg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 183 participants
Where: 35 sitesJapan
Study dates: Sep 2012to Jun 2013
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 20 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Has given written consent prior to any trial-related activity is performed
Male sex, aged 20 years or older
At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period
Has given agreement about contraception during the trial

Who cannot join

Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as >6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence
Chronic prostatitis/chronic pelvic pain syndrome
Psychogenic or habitual polydipsia
Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention

Show all 25Show fewer

Cancer
A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years
Genito-urinary tract pathology
Neurogenic detrusor activity
Suspicion or evidence of heart failure
Uncontrolled hypertension
Uncontrolled diabetes mellitus
Hepatobiliary diseases: Aspartate aminotransferase >80 U/L or alanine aminotransferase >90 U/L; Total bilirubin >1.5 mg/dL
Renal insufficiency: Serum creatinine level >1.09 mg/dL; Estimated glomerular filtration rate <50 mL/min
Hyponatraemia: Serum sodium level <135 mEq/L
Central or nephrogenic diabetes insipidus
Syndrome of inappropriate antidiuretic hormone
Obstructive sleep apnea
Previous desmopressin treatment
Treatment with another investigational product within the past 3 months
Concomitant treatment with any prohibited medication
Alcohol or substance abuse
A job or lifestyle that may interfere with regular night-time sleep
A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

Japan35 sites

Clinic Tsudanuma
Chiba
University of Fukui Hospital
Fukui
Kato Clinic
Gunma
Umeyama Clinic
Gunma
Harada Urology Clinic
Hyōgo
Sakaguchi Urological Clinic
Hyōgo
Nakamura Urology Clinic
Kanagawa
Nishi-Yokohama International Hospital
Kanagawa
Yokohama Shinmidori General Hospital
Kanagawa
Izumino Hospital, Bouchikai
Kochi
Kamei Clinic
Kochi
Den Urology Clinic
Osaka
Iwasa Clinic
Osaka
Kanno Clinic
Osaka
Morimoto Clinic
Osaka
Naka Clinic
Osaka
Uemura Clinic
Osaka
Urology department Kuroda Clinic
Osaka
Yamaguchi Clinic
Osaka
Yamanaka Clinic
Osaka
Fukuda Clinic
Saitama
Yasuda Urology Clinic
Saitama
Hirano Clinic
Tokyo
Hirata Internal Medicine Urology Clinic
Tokyo
J Tower Clinic
Tokyo
Koganeibashi Sakura Clinic
Tokyo
Kunitachi Sakura Hospital
Tokyo
Kusunoki Clinic
Tokyo
Moriguchi Clinic
Tokyo
Nakanoma Clinic Urology Department
Tokyo
Ogawa Clinic
Tokyo
Ogikubo Ekimae Clinic
Tokyo
Shibuya Shin-minamiguchi Clinic
Tokyo
Tokyo Kamata Hospital
Tokyo
Toru Clinic
Tokyo

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Men

Conditions: Nocturia
Being tested: A: Desmopressin 25 µg, B. Desmopressin 50 µg, Placebo
Medical subject headings: Nocturia

What participants receive

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

A: Desmopressin 25 µgDrug
B. Desmopressin 50 µgDrug
PlaceboDrug

Study groups in NCT01694498
Study group	Role	What they receive
A. Desmopressin 25 µg	Active comparator	1 orally disintegrating tablet every night during study period Receives: Drug: A: Desmopressin 25 µg
B. Desmopressin 50 µg	Active comparator	1 orally disintegrating tablet every night during study period Receives: Drug: B. Desmopressin 50 µg
C. Placebo	Placebo comparator	1 orally disintegrating tablet every night during study period Receives: Drug: 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 nocturnal voids
Measured: During 12 weeks

Secondary outcomes (10)

Change from baseline in mean time to first void
Measured: During 12 weeks
Responder status (33% reduction in nocturnal voids)
Measured: During 12 weeks
Change from baseline in mean number of nocturnal voids
Measured: 1, 4, 8 and 12 weeks
Change from baseline in mean time to first void
Measured: 1, 4, 8 and 12 weeks
Responder status (33% reduction in nocturnal voids)
Measured: 1, 4, 8 and 12 weeks
Change from baseline in mean nocturnal urine volume
Measured: 1, 4, 8 and 12 weeks
Change from baseline in nocturnal polyuria index
Measured: 1, 4, 8 and 12 weeks
Change from baseline in the effect on sleep disturbance
Measured: 1, 4, 8 and 12 weeks
Change from baseline in the impact on quality of life
Measured: 12 weeks
Adverse events, changes from baseline in serum sodium level, laboratory values
Measured: During 12 weeks

Timeline

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

Sep 2012Jun 2013

First posted27 Sep 2012 (estimated)
Study startSep 2012
Primary completionJun 2013
Study completionJun 2013

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01694498
Sponsor's protocol ID: 000030
Acronym: NOC
Status last verified: Aug 2013
First submitted: 11 Sep 2012
Last updated: 23 Aug 2013
Results posted: No
Data monitoring committee: No

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

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer

All Nocturia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Men
ClinicalTrials.gov ID: NCT01694498
Acronym / sponsor ID: NOC / 000030
Conditions: Nocturia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 27 Sep 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
A. Desmopressin 25 µg	Active comparator	Drug: A: Desmopressin 25 µg1 orally disintegrating tablet every night during study period
B. Desmopressin 50 µg	Active comparator	Drug: B. Desmopressin 50 µg1 orally disintegrating tablet every night during study period
C. Placebo	Placebo comparator	Drug: Placebo1 orally disintegrating tablet every night during study period

Who may qualify

Ages: 20 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Has given written consent prior to any trial-related activity is performed
Male sex, aged 20 years or older
At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period
Has given agreement about contraception during the trial

Key exclusion criteria (25 listed)

Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as >6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence
Chronic prostatitis/chronic pelvic pain syndrome
Psychogenic or habitual polydipsia

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
A: Desmopressin 25 µg	Drug	A. Desmopressin 25 µg
B. Desmopressin 50 µg	Drug	B. Desmopressin 50 µg
Placebo	Drug	C. Placebo

Primary outcome

Change from baseline in mean number of nocturnal voids
Time frame: During 12 weeks

10 secondary outcomes

Change from baseline in mean time to first void
Time frame: During 12 weeks
Responder status (33% reduction in nocturnal voids)
Time frame: During 12 weeks
Change from baseline in mean number of nocturnal voids
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in mean time to first void
Time frame: 1, 4, 8 and 12 weeks
Responder status (33% reduction in nocturnal voids)
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in mean nocturnal urine volume
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in nocturnal polyuria index
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in the effect on sleep disturbance
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in the impact on quality of life
Time frame: 12 weeks
Adverse events, changes from baseline in serum sodium level, laboratory values
Time frame: During 12 weeks

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 23 Aug 2013.

Related trials for Nocturia

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer

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.

Clinical Development Support study director

Ferring Pharmaceuticals

35 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 A: Desmopressin 25 µg and B. Desmopressin 50 µg in people with Nocturia, run by Ferring Pharmaceuticals at 35 sites in Japan.

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 25 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 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Japan. 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 nocturnal voids (time frame: During 12 weeks). 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 NCT01694498.

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 23 Aug 2013.