Clinical trial NCT01424228: Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: Long term
Constipation
Digestive signs and symptoms
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

Detailed description: In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.

The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.

Adult subjects (≥18 to \<65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).

Eligibility criteria: Inclusion Criteria:

1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule \[bisacodyl/enemas\].

Exclusion Criteria:

1. Subjects in whom constipation is thought to be drug-induced
2. Subjects using any disallowed medication.
3. Subjects who previously used prucalopride.
4. Subjects suffering from secondary causes of chronic constipation.

Primary outcomes:
measure: The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period
timeFrame: Over 24 week treatment period
Secondary outcomes:
measure: Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks
timeFrame: Over 24 week treatment period
measure: Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
timeFrame: Over 24 week treatment period
measure: Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
timeFrame: Over 24 week treatment period
measure: Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period
timeFrame: Over 24 week treatment period
measure: Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in Straining Per SCBM at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Time to First SCBM After Investigational Product Intake on Day 1 and Day 28
timeFrame: Day 1 and 28
measure: Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value
timeFrame: Baseline and Over 24 week treatment period
measure: Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value
timeFrame: Baseline and Over 24 week treatment period
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
state: Flemish Brabant
city: Brussel
country: Belgium
facility: Cliniques Universitaires St. Luc
city: Ham
country: Belgium
facility: Huisartspraktijk Jaak Mortelmans
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman Liège
city: Praha 4 - Krc
country: Czechia
facility: Fakultní Thomayerova nemocnice s poliklinikou
state: Praha
city: Ceské Budejovice
country: Czechia
facility: Derma Plus s.r.o.
city: Kolin
country: Czechia
facility: Oblastní nemocnice Kolín, a.s.
city: Ostrava-Hrabuvka
country: Czechia
facility: Diagnostika a Lécba Zažívacích Chorob, s.r.o.
city: Praha 1
country: Czechia
facility: MONSE s.r.o
city: Tabor
country: Czechia
facility: Nemocnice Tábor, a.s.
city: Ústí nad Orlicí
country: Czechia
facility: Orlickoústecká Nemocnice a.s
city: Gyula
country: Hungary
facility: Békés Megyei Képviselotestület Pándy Kálmán Kórháza
state: Bekes
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika
state: Csongrad
city: Szentes
country: Hungary
facility: Dr. Bugyi István Kórház
state: Csongrad
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
state: Gyor-moson-sopron
city: Mosonmagyaróvar
country: Hungary
facility: Karolina Kórház Rendelointézet
state: Gyor-moson-sopron
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Kórház
state: Pejer
city: Érd
country: Hungary
facility: Fundamed Háziorvosi Szövetkezet
state: Pest
city: Budapest
country: Hungary
facility: UNO Medical Trials, Kft.
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft.
city: Miskolc
country: Hungary
facility: BAZ Megyei és Egyetemi Oktató Kórház
city: Szekszárd
country: Hungary
facility: Clinfan Kft. SMO
city: Szikszó
country: Hungary
facility: CRU Hungary Kft.
city: Vác
country: Hungary
facility: Jávorszky Ödön Városi Kórház
city: Úrhida
country: Hungary
facility: Bíró Praxis Kft.
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Genova
country: Italy
facility: Azienda Ospedale San Martino
city: Padova
country: Italy
facility: Policlinico Universitario
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I di Roma
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne NZOZ
state: Malopolskie
city: Warszawa
country: Poland
facility: Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
state: Mazowieckie
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu
state: Opolskie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
state: Pomorskie
city: Czestochowa
country: Poland
facility: Centrum Medyczne sw. Lukasza Sp. z o.o.
state: Slaskie
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"
state: Zachodniopomorskie
city: Bucharest
country: Romania
facility: Spitalul Militar Central Bucuresti
state: Bucuresti
city: Bucharest
country: Romania
facility: Centrul Medical Sana
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean Cluj,Clinica Medicala I
state: Cluj
city: Craiova
country: Romania
facility: Biomed Plus SRL
state: Dolj
city: Bucharest
country: Romania
facility: SC Cabinet Medical Dr. Blaj Stefan SRL
state: Sector 5
city: Timisoara
country: Romania
facility: Centrul Medical Tuculanu SRL
state: Timis
city: Bucuresti
country: Romania
facility: Endocenter Medicina Integrativa SRL
city: Iasi
country: Romania
facility: Gastromedica SRL
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Targu-Mures
country: Romania
facility: CMI de Gastroenterologie Dobru Daniela
city: Timisoara
country: Romania
facility: Policlinic Algomed SRL
city: Bratislava
country: Slovakia
facility: Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
city: Košice
country: Slovakia
facility: Gastroenterologická ambulancia
city: Martin
country: Slovakia
facility: PIGEAS s.r.o.
city: Nitra
country: Slovakia
facility: Radvanská lekáren, spol. s r.o.,
city: Prešov
country: Slovakia
facility: Gastro I.s.r.o.
city: Trnava
country: Slovakia
facility: GEA s.r.o Gastroenterologicka ambulancia
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetsjukhuset
state: Vastra Gotaland
city: Stockholm
country: Sweden
facility: Aleris Specialistvård Sabbatsberg
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.
citation: Piessevaux H, Corazziari E, Rey E, Simren M, Wiechowska-Kozlowska A, Kerstens R, Cools M, Barrett K, Levine A. A randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of long-term treatment with prucalopride. Neurogastroenterol Motil. 2015 Jun;27(6):805-15. doi: 10.1111/nmo.12553. Epub 2015 Mar 25.