Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

NCT ID: NCT01424228

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-06
• Study Completion Date: 2012-12-19

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).

Conditions

Constipation

Study Design

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

Study Groups

Placebo

Placebo 2 mg tablet once daily before breakfast

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo matching tablet 2 mg once daily before breakfast for 24 weeks

prucalopride

Prucalopride 2 mg once daily before breakfast

Group Type: ACTIVE_COMPARATOR

prucalopride

Intervention Type: DRUG

Prucalopride 2 mg daily before breakfast

1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4

Interventions

placebo

Placebo matching tablet 2 mg once daily before breakfast for 24 weeks

Intervention Type: DRUG

prucalopride

Prucalopride 2 mg daily before breakfast

1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Universitaire Ziekenhuizen Leuven

Leuven, Flemish Brabant, Belgium

Cliniques Universitaires St. Luc

Brussels, , Belgium

Huisartspraktijk Jaak Mortelmans

Ham, , Belgium

Centre Hospitalier Universitaire Sart Tilman Liège

Liège, , Belgium

Fakultní Thomayerova nemocnice s poliklinikou

Praha 4 - Krc, Prague, Czechia

Derma Plus s.r.o.

České Budějovice, , Czechia

Oblastní nemocnice Kolín, a.s.

Kolín, , Czechia

Diagnostika a Lécba Zažívacích Chorob, s.r.o.

Ostrava-Hrabuvka, , Czechia

MONSE s.r.o

Prague, , Czechia

Nemocnice Tábor, a.s.

Tábor, , Czechia

Orlickoústecká Nemocnice a.s

Ústí nad Orlicí, , Czechia

Békés Megyei Képviselotestület Pándy Kálmán Kórháza

Gyula, Bekes County, Hungary

Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika

Szeged, Csongrád megye, Hungary

Dr. Bugyi István Kórház

Szentes, Csongrád megye, Hungary

Petz Aladár Megyei Oktató Kórház

Győr, Győr-Moson-Sopron, Hungary

Karolina Kórház Rendelointézet

Mosonmagyaróvar, Győr-Moson-Sopron, Hungary

Fejér Megyei Szent György Kórház

Székesfehérvár, Pejer, Hungary

Fundamed Háziorvosi Szövetkezet

Érd, Pest County, Hungary

UNO Medical Trials, Kft.

Budapest, , Hungary

Pannónia Magánorvosi Centrum Kft.

Budapest, , Hungary

BAZ Megyei és Egyetemi Oktató Kórház

Miskolc, , Hungary

Clinfan Kft. SMO

Szekszárd, , Hungary

CRU Hungary Kft.

Szikszó, , Hungary

Bíró Praxis Kft.

Úrhida, , Hungary

Jávorszky Ödön Városi Kórház

Vác, , Hungary

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Azienda Ospedale San Martino

Genova, , Italy

Policlinico Universitario

Padua, , Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, , Italy

Policlinico Universitario Campus Biomedico

Roma, , Italy

Azienda Policlinico Umberto I di Roma

Roma, , Italy

Krakowskie Centrum Medyczne NZOZ

Krakow, Lesser Poland Voivodeship, Poland

Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

Warsaw, Masovian Voivodeship, Poland

Szpital Wojewódzki w Opolu

Opole, Opole Voivodeship, Poland

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, Poland

Centrum Medyczne sw. Lukasza Sp. z o.o.

Częstochowa, Silesian Voivodeship, Poland

Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"

Szczecin, West Pomeranian Voivodeship, Poland

Spitalul Militar Central Bucuresti

Bucharest, București, Romania

Centrul Medical Sana

Bucharest, București, Romania

Spitalul Clinic Judetean Cluj,Clinica Medicala I

Cluj-Napoca, Cluj, Romania

Biomed Plus SRL

Craiova, Dolj, Romania

SC Cabinet Medical Dr. Blaj Stefan SRL

Bucharest, Sector 5, Romania

Centrul Medical Tuculanu SRL

Timișoara, Timiș County, Romania

Endocenter Medicina Integrativa SRL

Bucharest, , Romania

Gastromedica SRL

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, , Romania

CMI de Gastroenterologie Dobru Daniela

Târgu Mureş, , Romania

Policlinic Algomed SRL

Timișoara, , Romania

Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion

Bratislava, , Slovakia

Gastroenterologická ambulancia

Košice, , Slovakia

PIGEAS s.r.o.

Martin, , Slovakia

Radvanská lekáren, spol. s r.o.,

Nitra, , Slovakia

Gastro I.s.r.o.

Prešov, , Slovakia

GEA s.r.o Gastroenterologicka ambulancia

Trnava, , Slovakia

Hospital Parc Tauli

Sabadell, Barcelona, Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario Nuestra Señora de Valme

Seville, , Spain

Sahlgrenska Universitetsjukhuset

Gothenburg, Västra Götaland County, Sweden

Aleris Specialistvård Sabbatsberg

Stockholm, , Sweden

Karolinska University Hospital Solna

Stockholm, , Sweden

Countries

Belgium; Czechia; Hungary; Italy; Poland; Romania; Slovakia; Spain; Sweden

References

Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash BD. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Therap Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024.

Reference Type: DERIVED

PMID: 39664231 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34585675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25808103 (View on PubMed)

Other Identifiers

2011-000670-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD555-401

Identifier Type: OTHER

Identifier Source: secondary_id

M0001-C401

Identifier Type: -

Identifier Source: org_study_id