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

NCT01684800 | Completed Phase 2

• 1 other identifier: 000029
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean number of nocturnal voids

  During 12 weeks

Secondary Outcomes (10)

• Change from baseline in mean time to first void

  During 12 weeks

• Responder status (33% reduction in nocturnal voids)

  During 12 weeks

• Change from baseline in mean number of nocturnal voids

  1, 4, 8 and 12 weeks

• Change from baseline in mean time to first void

  1, 4, 8 and 12 weeks

• Responder status (33% reduction in nocturnal voids)

  1, 4, 8 and 12 weeks

Study Arms (3)

A. Desmopressin 10 microgram

ACTIVE COMPARATOR

Drug: A. Desmopressin 10 microgram

B. Desmopressin 25 microgram

ACTIVE COMPARATOR

Drug: B: Desmopressin 25 microgram

C. Placebo

PLACEBO COMPARATOR

Drug: C: Placebo

Interventions

A. Desmopressin 10 microgram DRUG

1 orally disintegrating tablet every night during study period

A. Desmopressin 10 microgram

B: Desmopressin 25 microgram DRUG

1 orally disintegrating tablet every night during study period

B. Desmopressin 25 microgram

C: Placebo DRUG

1 orally disintegrating tablet every night during study period

C. Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (36)

Japanese Red Cross Nagoya Daiichi Hospital

Aichi, Japan

Location

Clinic Tsudanuma

Chiba, Japan

Location

University of Fukui Hospital

Fukui, Japan

Location

Kato Clinic

Gunma, Japan

Location

Umeyama Clinic

Gunma, Japan

Location

Harada Urology Clinic

Hyōgo, Japan

Location

Sakaguchi Urological Clinic

Hyōgo, Japan

Location

Nakamura Urology Clinic

Kanagawa, Japan

Location

Nishi-Yokohama International Hospital

Kanagawa, Japan

Location

Yokohama Shinmidori General Hospital

Kanagawa, Japan

Location

Izumino Hospital, Bouchikai

Kochi, Japan

Location

Kamei Clinic

Kochi, Japan

Location

Den Urology Clinic

Osaka, Japan

Location

Iwasa Clinic

Osaka, Japan

Location

Kanno Clinic

Osaka, Japan

Location

Morimoto Clinic

Osaka, Japan

Location

Naka Clinic

Osaka, Japan

Location

Uemura Clinic

Osaka, Japan

Location

Urology department Kuroda Clinic

Osaka, Japan

Location

Yamaguchi Clinic

Osaka, Japan

Location

Yamanaka Clinic

Osaka, Japan

Location

Fukuda Clinic

Saitama, Japan

Location

Yasuda Urology Clinic

Saitama, Japan

Location

Hirano Clinic

Tokyo, Japan

Location

Hirata Internal Medicine Urology Clinic

Tokyo, Japan

Location

J Tower Clinic

Tokyo, Japan

Location

Koganeibashi Sakura Clinic

Tokyo, Japan

Location

Kunitachi Sakura Hospital

Tokyo, Japan

Location

Kusunoki Clinic

Tokyo, Japan

Location

Moriguchi Clinic

Tokyo, Japan

Location

Nakanoma Clinic Urology Department

Tokyo, Japan

Location

Ogawa Clinic

Tokyo, Japan

Location

Ogikubo Ekimae Clinic

Tokyo, Japan

Location

Shibuya Shin-minamiguchi Clinic

Tokyo, Japan

Location

Tokyo Kamata Hospital

Tokyo, Japan

Location

Toru Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Development Support

  Ferríng Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 23, 2013

Record last verified: 2013-08

Locations

JP (36)