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

NCT ID: NCT01684800

Last Updated: 2013-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-06-30

Brief 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 women during 12 weeks treatment

Conditions

Nocturia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A. Desmopressin 10 microgram

Group Type: ACTIVE_COMPARATOR

A. Desmopressin 10 microgram

Intervention Type: DRUG

1 orally disintegrating tablet every night during study period

B. Desmopressin 25 microgram

Group Type: ACTIVE_COMPARATOR

B: Desmopressin 25 microgram

Intervention Type: DRUG

1 orally disintegrating tablet every night during study period

C. Placebo

Group Type: PLACEBO_COMPARATOR

C: Placebo

Intervention Type: DRUG

1 orally disintegrating tablet every night during study period

Interventions

A. Desmopressin 10 microgram

1 orally disintegrating tablet every night during study period

Intervention Type: DRUG

B: Desmopressin 25 microgram

1 orally disintegrating tablet every night during study period

Intervention Type: DRUG

C: Placebo

1 orally disintegrating tablet every night during study period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has given written consent prior to any trial-related activity is performed.
• Female 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.

Exclusion Criteria

• Showing symptoms of any of the following diseases: 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.
• 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.
• 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 >0.82 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.
• Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferríng Pharmaceuticals

Locations

Japanese Red Cross Nagoya Daiichi Hospital

Aichi, , Japan

Clinic Tsudanuma

Chiba, , Japan

University of Fukui Hospital

Fukui, , Japan

Kato Clinic

Gunma, , Japan

Umeyama Clinic

Gunma, , Japan

Harada Urology Clinic

Hyōgo, , Japan

Sakaguchi Urological Clinic

Hyōgo, , Japan

Nakamura Urology Clinic

Kanagawa, , Japan

Nishi-Yokohama International Hospital

Kanagawa, , Japan

Yokohama Shinmidori General Hospital

Kanagawa, , Japan

Izumino Hospital, Bouchikai

Kochi, , Japan

Kamei Clinic

Kochi, , Japan

Den Urology Clinic

Osaka, , Japan

Iwasa Clinic

Osaka, , Japan

Kanno Clinic

Osaka, , Japan

Morimoto Clinic

Osaka, , Japan

Naka Clinic

Osaka, , Japan

Uemura Clinic

Osaka, , Japan

Urology department Kuroda Clinic

Osaka, , Japan

Yamaguchi Clinic

Osaka, , Japan

Yamanaka Clinic

Osaka, , Japan

Fukuda Clinic

Saitama, , Japan

Yasuda Urology Clinic

Saitama, , Japan

Hirano Clinic

Tokyo, , Japan

Hirata Internal Medicine Urology Clinic

Tokyo, , Japan

J Tower Clinic

Tokyo, , Japan

Koganeibashi Sakura Clinic

Tokyo, , Japan

Kunitachi Sakura Hospital

Tokyo, , Japan

Kusunoki Clinic

Tokyo, , Japan

Moriguchi Clinic

Tokyo, , Japan

Nakanoma Clinic Urology Department

Tokyo, , Japan

Ogawa Clinic

Tokyo, , Japan

Ogikubo Ekimae Clinic

Tokyo, , Japan

Shibuya Shin-minamiguchi Clinic

Tokyo, , Japan

Tokyo Kamata Hospital

Tokyo, , Japan

Toru Clinic

Tokyo, , Japan

Countries

Japan

Other Identifiers

000029

Identifier Type: -

Identifier Source: org_study_id