Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis (PNE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01078753

First received: March 1, 2010

Last updated: September 27, 2011

Last verified: September 2011

History of Changes

Results First Received: September 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Nocturnal Enuresis
Interventions:	Drug: Desmopressin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
174 subjects consented and entered the 14-day screening period during which Baseline characteristics regarding enuretic episodes were established. Eligible patients who met the criterion were randomized 1:1 to receive either desmopressin or matching placebo. Randomization was stratified by gender, age and number of wet nights at Baseline.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

174 subjects consented and entered the 14-day screening period during which Baseline characteristics regarding enuretic episodes were established. Eligible patients who met the criterion were randomized 1:1 to receive either desmopressin or matching placebo.

Randomization was stratified by gender, age and number of wet nights at Baseline.

Reporting Groups

Description

Desmopressin

During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.

Placebo

Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.

Participant Flow for 2 periods

Period 1: Treatment Period I

	Desmopressin	Placebo
STARTED	45	44
Full Analysis Set	44 ^[1]	44
COMPLETED	45	44
NOT COMPLETED	0	0

[1]	One patient was excluded from the full analysis set due to failure to satisfy the entry criteria.

Period 2: Treatment Period II

	Desmopressin	Placebo
STARTED	45 ^[1]	44
Full Analysis Set	44 ^[2]	44
COMPLETED	45	44
NOT COMPLETED	0	0

[1]	Desmopressin 120 µg - 4 participants Desmopressin 240 µg - 41 participants
[2]	One patient was excluded from the full analysis set due to failure to satisfy the entry criteria.

Baseline Characteristics

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Reporting Groups

	Description
Desmopressin	During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
Placebo	Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
Total	Total of all reporting groups

Baseline Measures

	Desmopressin	Placebo	Total
Number of Participants [units: participants]	45	44	89
Age [units: years] Mean ± Standard Deviation	8.2 ± 1.6	8.1 ± 1.4	8.1 ± 1.5
Age, Customized [units: participants]
6 to 9 years old	36	36	72
10 to15 years old	9	8	17
Gender [units: participants]
Female	17	21	38
Male	28	23	51
Region of Enrollment [units: participants]
Japan	45	44	89
Height [units: cm] Mean ± Standard Deviation	128.14 ± 11.30	127.68 ± 8.61	127.92 ± 10.01
Weight [units: kg] Mean ± Standard Deviation	27.59 ± 8.40	27.01 ± 5.32	27.30 ± 7.01
Body Mass Index (BMI) [units: kg/m˄2] Mean ± Standard Deviation	16.46 ± 2.47	16.43 ± 1.77	16.44 ± 2.14
Number of Wet Nights during Baseline ^[1] [units: days] Mean ± Standard Deviation	12.2 ± 1.5	12.4 ± 1.5	12.3 ± 1.5
Number of Wet Nights during Baseline by stratification criteria ^[2] [units: participants]
10 to 13 wet nights	32	30	62
14 wet nights	13	14	27
Prior treatment of Nocturnal Enuresis with Drugs [units: participants]
No prior treatment	45	44	89
Prior treatment received	0	0	0
Prior treatment of Nocturnal Enuresis with Therapy ^[3] [units: participants]
No prior therapy	0	0	0
Prior therapy	45	44	89

[1]	Number of Wet Nights recorded during the 14-day Baseline period.
[2]	The number of wet nights recorded during the 14-day Baseline period is reported for each of the stratification categories.
[3]	Therapies for treatment of Nocturnal Enuresis might include life-skill guidance, bladder control training, psychotherapy, or behaviour conditioning therapy.

Outcome Measures

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1. Primary:

Change in the Number of Wet Nights Between Baseline and Treatment Period II [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation). ]

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2. Secondary:

Change in Number of Wet Nights Between Baseline and Treatment Period I [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). ]

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3. Secondary:

Change in Number of Wet Nights Between Treatment Periods I and II [ Time Frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01078753 History of Changes
Other Study ID Numbers:	FE992026 CS35
Study First Received:	March 1, 2010
Results First Received:	September 27, 2011
Last Updated:	September 27, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

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