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

NCT01424228 | Completed Phase 4 Results

• 3 other identifiers: M0001-C4012011-000670-62SPD555-401
• Study Type: interventional
• Target: 364
• Locations: 9 countries
• Sites: 60

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.

Conditions

Constipation

Keywords

Long term; Constipation; Digestive signs and symptoms

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period

  Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

  Over 24 week treatment period

Secondary Outcomes (16)

• Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks

  Over 24 week treatment period

• Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks

  Over 24 week treatment period

• Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks

  Baseline and Over 24 week treatment period

• Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week

  Over 24 week treatment period

• Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period

  Over 24 week treatment period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 2 mg tablet once daily before breakfast

Drug: placebo

prucalopride

ACTIVE COMPARATOR

Prucalopride 2 mg once daily before breakfast

Drug: prucalopride

Interventions

placebo DRUG

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

Placebo

prucalopride 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

prucalopride

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shire: lead

Study Sites (60)

Universitaire Ziekenhuizen Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Cliniques Universitaires St. Luc

Brussels, 1200, Belgium

Location

Huisartspraktijk Jaak Mortelmans

Ham, 3945, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman Liège

Liège, 4000, Belgium

Location

Fakultní Thomayerova nemocnice s poliklinikou

Praha 4 - Krc, Prague, 140 59, Czechia

Location

Derma Plus s.r.o.

České Budějovice, 370 01, Czechia

Location

Oblastní nemocnice Kolín, a.s.

Kolín, 280 20, Czechia

Location

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

Ostrava-Hrabuvka, 700 30, Czechia

Location

MONSE s.r.o

Prague, 118 33, Czechia

Location

Nemocnice Tábor, a.s.

Tábor, 390 03, Czechia

Location

Orlickoústecká Nemocnice a.s

Ústí nad Orlicí, 562 18, Czechia

Location

Békés Megyei Képviselotestület Pándy Kálmán Kórháza

Gyula, Bekes County, 5700, Hungary

Location

Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika

Szeged, Csongrád megye, 6720, Hungary

Location

Dr. Bugyi István Kórház

Szentes, Csongrád megye, 6600, Hungary

Location

Petz Aladár Megyei Oktató Kórház

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Karolina Kórház Rendelointézet

Mosonmagyaróvar, Győr-Moson-Sopron, 9200, Hungary

Location

Fejér Megyei Szent György Kórház

Székesfehérvár, Pejer, 8000, Hungary

Location

Fundamed Háziorvosi Szövetkezet

Érd, Pest County, 2030, Hungary

Location

UNO Medical Trials, Kft.

Budapest, 1135, Hungary

Location

Pannónia Magánorvosi Centrum Kft.

Budapest, 1136, Hungary

Location

BAZ Megyei és Egyetemi Oktató Kórház

Miskolc, 3526, Hungary

Location

Clinfan Kft. SMO

Szekszárd, 7100, Hungary

Location

CRU Hungary Kft.

Szikszó, 3800, Hungary

Location

Bíró Praxis Kft.

Úrhida, 8142, Hungary

Location

Jávorszky Ödön Városi Kórház

Vác, 2600, Hungary

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedale San Martino

Genova, 16132, Italy

Location

Policlinico Universitario

Padua, 35128, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, 00128, Italy

Location

Azienda Policlinico Umberto I di Roma

Roma, 00161, Italy

Location

Krakowskie Centrum Medyczne NZOZ

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

Warsaw, Masovian Voivodeship, 02-653, Poland

Location

Szpital Wojewódzki w Opolu

Opole, Opole Voivodeship, 45-061, Poland

Location

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, 81-756, Poland

Location

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

Częstochowa, Silesian Voivodeship, 42-202, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"

Szczecin, West Pomeranian Voivodeship, 70-361, Poland

Location

Spitalul Militar Central Bucuresti

Bucharest, București, 010825, Romania

Location

Centrul Medical Sana

Bucharest, București, 011025, Romania

Location

Spitalul Clinic Judetean Cluj,Clinica Medicala I

Cluj-Napoca, Cluj, 400006, Romania

Location

Biomed Plus SRL

Craiova, Dolj, 200347, Romania

Location

SC Cabinet Medical Dr. Blaj Stefan SRL

Bucharest, Sector 5, 040101, Romania

Location

Centrul Medical Tuculanu SRL

Timișoara, Timiș County, 300158, Romania

Location

Endocenter Medicina Integrativa SRL

Bucharest, 021978, Romania

Location

Gastromedica SRL

Iași, 700506, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, 550245, Romania

Location

CMI de Gastroenterologie Dobru Daniela

Târgu Mureş, 540103, Romania

Location

Policlinic Algomed SRL

Timișoara, 300002, Romania

Location

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

Bratislava, 811 07, Slovakia

Location

Gastroenterologická ambulancia

Košice, 040 01, Slovakia

Location

PIGEAS s.r.o.

Martin, 03601, Slovakia

Location

Radvanská lekáren, spol. s r.o.,

Nitra, 950 01, Slovakia

Location

Gastro I.s.r.o.

Prešov, 08001, Slovakia

Location

GEA s.r.o Gastroenterologicka ambulancia

Trnava, 91701, Slovakia

Location

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, 41014, Spain

Location

Sahlgrenska Universitetsjukhuset

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Aleris Specialistvård Sabbatsberg

Stockholm, 113 82, Sweden

Location

Karolinska University Hospital Solna

Stockholm, 171 76, Sweden

Location

Related Publications (3)

• 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.

  PMID: 39664231 DERIVED

• 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.

  PMID: 34585675 DERIVED

• 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.

  PMID: 25808103 DERIVED

MeSH Terms

Conditions

Constipation; Signs and Symptoms, Digestive

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 26, 2011
• Study Start: April 6, 2011
• Primary Completion: December 19, 2012
• Study Completion: December 19, 2012
• Last Updated: June 11, 2021
• Results First Posted: April 2, 2014

Record last verified: 2021-05

Locations

IT (6); ES (3); SE (3); SL (6); PL (6); HU (14); RO (11); CZ (7); BE (4)