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CompletedNCT01424228SPD555-401Updated Jun 11, 2021Results posted

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

A Phase 4 interventional study of placebo and prucalopride in Constipation, sponsored by Shire. Completed at 60 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Shire · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2011, registered Aug 2011).
Phase
Phase 4
Study type
Interventional
Enrollment
364
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Constipation

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Keywords

  • Long term
  • Constipation
  • Digestive signs and symptoms
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 364 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
364 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo 2 mg tablet once daily before breakfast

    Drug: placebo

  • Active comparator
    prucalopride

    Prucalopride 2 mg once daily before breakfast

    Drug: prucalopride

Interventions

  • Drugplacebo

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

  • Drugprucalopride

    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

06

What researchers measure

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.

    Time frame: Over 24 week treatment period

Secondary outcomes

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

    Time frame: Over 24 week treatment period

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

    Time frame: Over 24 week treatment period

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

    Time frame: Baseline and Over 24 week treatment period

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

    Time frame: Over 24 week treatment period

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

    Time frame: Over 24 week treatment period

  6. Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks

    Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.

    Time frame: Baseline and Over 24 week treatment period

  7. Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  8. Change From Baseline in Straining Per SCBM at Up to 24 Weeks

    Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)

    Time frame: Baseline and Over 24 week treatment period

  9. Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  10. Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  11. Time to First SCBM After Investigational Product Intake on Day 1 and Day 28

    Time frame: Day 1 and 28

  12. Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  13. Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks

    Rescue medications include laxatives and enemas.

    Time frame: Baseline and Over 24 week treatment period

  14. Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value

    The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.

    Time frame: Baseline and Over 24 week treatment period

  15. Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value

    The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.

    Time frame: Baseline and Over 24 week treatment period

  16. Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value

    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.

    Time frame: Baseline and Over 24 week treatment period

07

Results

Posted Apr 2, 2014

Participant flow

Participant flow — Overall Study
MilestonePlaceboPrucalopride
Started182182
Completed126135
Not completed5647
Withdrew: Withdrawal by subject2711
Withdrew: Adverse event1014
Withdrew: Sponsor's decision912
Withdrew: Lack of efficacy57
Withdrew: Inclusion/exclusion criteria not met22
Withdrew: Non-compliance20
Withdrew: Worsening of symptoms10
Withdrew: Unplanned journey01

Outcome measures

PrimaryThe 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.

Time frame:
Over 24 week treatment period
Reported as:
Number · percentage of subjects
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period
percentage of subjectsPlaceboPrucalopride
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period20.725.1
Statistical analysis
  • Placebo vs Prucalopride · Cochran-Mantel-Haenszel · p = 0.367
SecondaryPercentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks
Time frame:
Over 24 week treatment period
Reported as:
Number · percentage of subjects
Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks
percentage of subjectsPlaceboPrucalopride
Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks42.048.0
SecondaryAverage Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
Time frame:
Over 24 week treatment period
Reported as:
Mean · SCBM/week
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
SCBM/weekPlaceboPrucalopride
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks1.7 ± 1.862.1 ± 1.96
SecondaryChange From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · SCBM/week
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
SCBM/weekPlaceboPrucalopride
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks1.3 ± 1.771.7 ± 1.90
SecondaryPercent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
Time frame:
Over 24 week treatment period
Reported as:
Number · percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
percentage of subjectsPlaceboPrucalopride
Week 118.332.2
Week 223.134.5
Week 322.532.2
Week 423.131.6
Week 526.627.5
Week 628.429.2
Week 729.029.8
Week 826.030.4
Week 927.833.3
Week 1026.030.4
Week 1125.437.4
Week 1227.233.9
Week 1323.730.4
Week 1430.235.7
Week 1524.929.2
Week 1629.635.1
Week 1728.435.1
Week 1830.232.7
Week 1932.032.2
Week 2024.937.4
Week 2126.630.4
Week 2227.832.7
Week 2330.231.0
Week 2432.031.6
SecondaryPercent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period
Time frame:
Over 24 week treatment period
Reported as:
Number · percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period
percentage of subjectsPlaceboPrucalopride
First 4-week period18.326.9
Second 4-week period23.725.7
Third 4-week period23.729.2
Fourth 4-week period22.529.2
Fifth 4-week period23.733.3
Sixth 4-week period24.926.9
SecondaryChange From Baseline in Average Consistency Per SCBM at Up to 24 Weeks

Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.

Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · units on a scale
Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks
units on a scalePlaceboPrucalopride
Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks-0.1 ± 1.79-0.1 ± 1.31
SecondaryChange From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks
Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · percentage of SCBM
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks
percentage of SCBMPlaceboPrucalopride
Normal consistency16.82 ± 42.36525.71 ± 40.1
Hard/Very Hard consistency-9.11 ± 41.495-13.82 ± 31.349
SecondaryChange From Baseline in Straining Per SCBM at Up to 24 Weeks

Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)

Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · units on a scale
Change From Baseline in Straining Per SCBM at Up to 24 Weeks
units on a scalePlaceboPrucalopride
Change From Baseline in Straining Per SCBM at Up to 24 Weeks-0.44 ± 0.948-0.23 ± 0.870
SecondaryChange From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks
Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · percentage of SCBM
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks
percentage of SCBMPlaceboPrucalopride
No straining11.14 ± 39.7866.61 ± 33.916
Severe/Very Severe straining-9.85 ± 29.711-4.49 ± 28.177
SecondaryChange From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks
Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · percentage of SBM
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks
percentage of SBMPlaceboPrucalopride
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks20.94 ± 32.61924.22 ± 32.878
SecondaryTime to First SCBM After Investigational Product Intake on Day 1 and Day 28
Time frame:
Day 1 and 28
Reported as:
Median · hours
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28
hoursPlaceboPrucalopride
Day 1359.67 (179.6 to 461.42)100.83 (74.0 to 170.75)
Day 28100.58 (75.2 to 199.02)81.78 (52.25 to 151.05)
SecondaryChange From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks
Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · tablets/week
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks
tablets/weekPlaceboPrucalopride
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks-0.68 ± 1.583-0.97 ± 1.821
SecondaryChange From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks

Rescue medications include laxatives and enemas.

Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · days/week
Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks
days/weekPlaceboPrucalopride
Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks-0.42 ± 0.892-0.54 ± 1.018
SecondaryChange From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value

The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.

Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · units on a scale
Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value
units on a scalePlaceboPrucalopride
Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value-0.68 ± 0.929-0.55 ± 0.794
SecondaryChange From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value

The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.

Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · units on a scale
Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value
units on a scalePlaceboPrucalopride
Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value-0.73 ± 0.902-0.67 ± 0.932
SecondaryChange From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value

The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.

Time frame:
Baseline and Over 24 week treatment period
Reported as:
Mean · units on a scale
Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value
units on a scalePlaceboPrucalopride
Mental component3.786 ± 10.08873.179 ± 10.5714
Physical component3.331 ± 6.98302.965 ± 6.9320

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—4/180 (2.2%)23/180 (12.8%)
Prucalopride—4/181 (2.2%)41/181 (22.7%)
Most frequent serious events
Most frequent serious events
EventPlaceboPrucalopride
Colitis ischemicGastrointestinal disorders1/1800/181
Cholecystitis chronicHepatobiliary disorders1/1800/181
Vestibular neuronitisInfections and infestations1/1800/181
Ischemic strokeNervous system disorders1/1800/181
Orthostatic hypotensionVascular disorders1/1800/181
Obstruction gastricGastrointestinal disorders0/1801/181
Blood pressure decreasedInvestigations0/1801/181
Electrocardiogram QT prolongedInvestigations0/1801/181
Cerebrovascular accidentNervous system disorders0/1801/181
Abnormal behaviorPsychiatric disorders0/1801/181
Most frequent other events
Most frequent other events
EventPlaceboPrucalopride
HeadacheNervous system disorders10/18021/181
Abdominal painGastrointestinal disorders8/18018/181
NauseaGastrointestinal disorders7/18013/181

Baseline characteristics

The Safety Population was used for demographics. The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).

Age, Continuous
Age, Continuous(years)PlaceboPrucaloprideTotal
Mean48.3 ± 16.2549.4 ± 15.7848.9 ± 16.00
Age, Customized
Age, Customized(Participants)PlaceboPrucaloprideTotal
<65 years149146295
> = 65 years to <75 years202646
>=75 years11920
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPrucaloprideTotal
Female153155308
Male272653
Region of Enrollment
Region of Enrollment(Participants)PlaceboPrucaloprideTotal
Romania383775
Poland343165
Hungary293160
Slovakia282957
Italy191837
Spain11819
Belgium81119
Sweden9918
Czech Republic6814
08

Study locations

60 sites
  • Universitaire Ziekenhuizen Leuven
    Leuven, Flemish Brabant 3000, Belgium
  • Cliniques Universitaires St. Luc
    Brussel, 1200, Belgium
  • Huisartspraktijk Jaak Mortelmans
    Ham, 3945, Belgium
  • Centre Hospitalier Universitaire Sart Tilman Liège
    Liège, 4000, Belgium
  • Fakultní Thomayerova nemocnice s poliklinikou
    Praha 4 - Krc, Praha 140 59, Czechia
  • Derma Plus s.r.o.
    Ceské Budejovice, 370 01, Czechia
  • Oblastní nemocnice Kolín, a.s.
    Kolin, 280 20, Czechia
  • Diagnostika a Lécba Zažívacích Chorob, s.r.o.
    Ostrava-Hrabuvka, 700 30, Czechia
  • MONSE s.r.o
    Praha 1, 118 33, Czechia
  • Nemocnice Tábor, a.s.
    Tabor, 390 03, Czechia
  • Orlickoústecká Nemocnice a.s
    Ústí nad Orlicí, 562 18, Czechia
  • Békés Megyei Képviselotestület Pándy Kálmán Kórháza
    Gyula, Bekes 5700, Hungary
  • Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika
    Szeged, Csongrad 6720, Hungary
  • Dr. Bugyi István Kórház
    Szentes, Csongrad 6600, Hungary
  • Petz Aladár Megyei Oktató Kórház
    Gyor, Gyor-moson-sopron 9024, Hungary
  • Karolina Kórház Rendelointézet
    Mosonmagyaróvar, Gyor-moson-sopron 9200, Hungary
  • Fejér Megyei Szent György Kórház
    Székesfehérvár, Pejer 8000, Hungary
  • Fundamed Háziorvosi Szövetkezet
    Érd, Pest 2030, Hungary
  • UNO Medical Trials, Kft.
    Budapest, 1135, Hungary
  • Pannónia Magánorvosi Centrum Kft.
    Budapest, 1136, Hungary
  • BAZ Megyei és Egyetemi Oktató Kórház
    Miskolc, 3526, Hungary
  • Clinfan Kft. SMO
    Szekszárd, 7100, Hungary
  • CRU Hungary Kft.
    Szikszó, 3800, Hungary
  • Jávorszky Ödön Városi Kórház
    Vác, 2600, Hungary
  • Bíró Praxis Kft.
    Úrhida, 8142, Hungary
  • Istituto Clinico Humanitas
    Rozzano, Milano 20089, Italy
  • Azienda Ospedale San Martino
    Genova, 16132, Italy
  • Policlinico Universitario
    Padova, 35128, Italy
  • Fondazione IRCCS Policlinico S. Matteo
    Pavia, 27100, Italy
  • Policlinico Universitario Campus Biomedico
    Roma, 00128, Italy
  • Azienda Policlinico Umberto I di Roma
    Roma, 00161, Italy
  • Krakowskie Centrum Medyczne NZOZ
    Krakow, Malopolskie 31-501, Poland
  • Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
    Warszawa, Mazowieckie 02-653, Poland
  • Szpital Wojewódzki w Opolu
    Opole, Opolskie 45-061, Poland
  • Endoskopia Sp. z o.o.
    Sopot, Pomorskie 81-756, Poland
  • Centrum Medyczne sw. Lukasza Sp. z o.o.
    Czestochowa, Slaskie 42-202, Poland
  • Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"
    Szczecin, Zachodniopomorskie 70-361, Poland
  • Spitalul Militar Central Bucuresti
    Bucharest, Bucuresti 010825, Romania
  • Centrul Medical Sana
    Bucharest, Bucuresti 011025, Romania
  • Spitalul Clinic Judetean Cluj,Clinica Medicala I
    Cluj-Napoca, Cluj 400006, Romania
  • Biomed Plus SRL
    Craiova, Dolj 200347, Romania
  • SC Cabinet Medical Dr. Blaj Stefan SRL
    Bucharest, Sector 5 040101, Romania
  • Centrul Medical Tuculanu SRL
    Timisoara, Timis 300158, Romania
  • Endocenter Medicina Integrativa SRL
    Bucuresti, 021978, Romania
  • Gastromedica SRL
    Iasi, 700506, Romania
  • Spitalul Clinic Judetean de Urgenta Sibiu
    Sibiu, 550245, Romania
  • CMI de Gastroenterologie Dobru Daniela
    Targu-Mures, 540103, Romania
  • Policlinic Algomed SRL
    Timisoara, 300002, Romania
  • Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
    Bratislava, 811 07, Slovakia
  • Gastroenterologická ambulancia
    Košice, 040 01, Slovakia
  • PIGEAS s.r.o.
    Martin, 03601, Slovakia
  • Radvanská lekáren, spol. s r.o.,
    Nitra, 950 01, Slovakia
  • Gastro I.s.r.o.
    Prešov, 08001, Slovakia
  • GEA s.r.o Gastroenterologicka ambulancia
    Trnava, 91701, Slovakia
  • Hospital Parc Tauli
    Sabadell, Barcelona 08208, Spain
  • Hospital Clínico San Carlos
    Madrid, 28040, Spain
  • Hospital Universitario Nuestra Señora de Valme
    Sevilla, 41014, Spain
  • Sahlgrenska Universitetsjukhuset
    Göteborg, Vastra Gotaland 413 45, Sweden
  • Aleris Specialistvård Sabbatsberg
    Stockholm, 113 82, Sweden
  • Karolinska University Hospital Solna
    Stockholm, 171 76, Sweden
09

References and documents

Publications

  • 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. PubMed 34585675 ↗
  • 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. PubMed 25808103 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01424228
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Aug 26, 2011
Start date
Apr 6, 2011
Primary completion
Dec 19, 2012
Completion
Dec 19, 2012
Results posted
Apr 2, 2014
Last update
Jun 11, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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