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Male Subjects With Chronic ConstipationPhase 3NCT01147926

Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

A Phase 3 study testing Prucalopride in people with Male Subjects With Chronic Constipation, run by Shire at 73 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Male Subjects With Chronic Constipation
What is being tested?
Prucalopride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
73 sitesin 10 countries
Study dates
23 Sep 2010to 25 Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is a male 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) and one or more of the following for at least 6 months before the selection visit:
  • Very hard (little balls) and/or hard stools for at least a quarter of the stools;
  • Sensation of incomplete evacuation following for at least a quarter of the stools;
  • Straining at defecation for at least a quarter of the time. This includes subjects who never have SBMs. The above criteria are only applicable for SBMs, i.e. BMs not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
  • Subject agrees to stop his current laxative treatment and is willing to use rescue medication according to the rescue rule [Dulcolax® (bisacodyl)/enemas]
Show all 10Show fewer
  • Subject's constipation is chronic.
  • Subject is able and willing to complete the questionnaires (if a validated version in the language of the subject is available) and the e-diary.
  • Subject voluntarily signs the written Informed Consent Form (ICF) in accordance with the regional laws/regulations, prior to the first trial-related activity.
  • Subject is willing to adhere to all trial requirements (amongst others colonoscopy/sigmoidoscopy, if required).

Who cannot join

  • Subjects in whom constipation is thought to be drug-induced.
  • Subjects using any disallowed medication
  • Subjects suffering from secondary causes of chronic constipation, such as:
  • Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcaemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumours, unless these are controlled by appropriate medical therapy. Subjects with insulin-dependent diabetes mellitus should always be excluded, also if the subjects are under appropriate medical therapy; Metabolic disorders (e.g. porphyria, uraemia, hypokalaemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy); Neurological disorders (e.g. Parkinson's disease, cerebral tumours, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, major depression); Surgery. Subjects with insulin-dependent diabetes mellitus should always be excluded, irrespective of whether the constipation started prior to or after the onset of diabetes.
  • Subjects with a significant history of cancer (i.e. less than a 5-year disease-free survival).
  • Subjects with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease, and ulcerative colitis and toxic megacolon/megarectum. Results of an endoscopy or radiologic bowel evaluation is required to rule out polyps, cancer, stricture or other structural or organic disease:
Show all 19Show fewer
  • For patients ≤ 50 years: a flexible sigmoidoscopy or colonoscopy after the onset of constipation symptoms and within the previous 5 years;
  • For patients > 50 years: a flexible sigmoidoscopy /double contrast barium enema or colonoscopy after the onset of constipation symptoms and within the previous 5 years.
  • For subjects, regardless of age, even if results of this test are available within the previous 5 years but if the patient has alarm symptoms such as anemia, weight loss, heme positive stool, or rectal bleeding: a flexible sigmoidoscopy and double contrast barium enema or colonoscopy is needed after the onset of symptoms.
  • If abnormalities have been detected during the sigmoidoscopy or colonoscopy e.g., because of polyps, the subject can be included in the trial if the polyps were removed. If clinically indicated, a repeat colonoscopy/sigmoidoscopy needs to be performed at latest within one week after the screening visit. If no barium enema with flexible sigmoidoscopy or a colonoscopic examination has been performed within the period as described above, the assessment is to be scheduled on the screening visit or within the week following screening. When it is clinically indicated that a repeat colonoscopy/sigmoidoscopy is needed to confirm results of a colonoscopy/sigmoidoscopy performed after the screening visit, the subject should be a screen failure.
  • Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
  • Subjects with any condition that in the opinion of the Investigator would complicate or compromise the trial or the well-being of the subject or evidence of clinically relevant pathology that could interfere with the trial results or put the subject's safety at risk.
  • Subjects known to have human immunodeficiency virus (HIV) infection or AIDS, hepatitis B or hepatitis C.
  • Subjects with impaired renal function, i.e. serum creatinine concentration >180 μmol/l or calculated creatinine clearance ≤30 ml/min, including subjects requiring dialysis.
  • Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry as determined by the Investigator. If the results of the haematology, biochemistry or urinalysis tests are not within the laboratory's reference ranges, the subject can be included only on the condition that the Investigator judges that the deviations are not clinically significant. This should be clearly recorded in the electronic Case Report Form (e-CRF).
  • Subjects with a known history of alcohol or drug abuse in the previous 6 months.
  • Subjects with lactose intolerance for whom it is expected that low doses of lactose can lead to diarrhoea, or a known allergy to ingredients or excipients of the trial medication.
  • Subjects who received an investigational drug in the 30 days preceding the run-in period of the trial.
  • Subjects who previously used prucalopride.

Trial locations and contacts

73 sites in 10 countries.

73 sites in 10 countries

Romania16 sites

  • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

    Bucharest, Sector 1, 010825

  • SC Quantum Medical Center SRL

    Bucharest, Sector 1, 011426

  • Endocenter Medicina Integrativa SRL

    Bucharest, Sector 2, 021978

  • SC Mediclass Sananova SRL

    Bucharest, Sector 5, 050524

  • SC Cabinet Medical Dr. Blaj Stefan SRL

    Bucharest, Sector 5, 40101

  • Centrul Medical Humanitas

    Bucharest, Sector 6, 062272

  • Centrul Medical Sana

    Bucharest, 11025

  • Spitalul Clinic Judetean Cluj,Clinica Medicala I

    Cluj-Napoca, 400006

  • Gastromedica SRL

    Iași, 700506

  • Cabinet Medical Dr. Lokos Barna-Csaba

    Miercurea-Ciuc, 530174

  • CMI Dr. Lenghel Augustin

    Oradea, Bihor County, 410163

  • Centrul Medical Valahia SRL

    Ploieşti, Prahova, 100410

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • CMI de Gastroenterologie Dobru Daniela

    Târgu Mureş, 540130

  • Centrul Medical Tuculanu SRL

    Timișoara, Timiș County, 300158

  • Policlinic Algomed SRL

    Timișoara, 300002

Other trials in Romania

France13 sites

  • CHU - Hopital Nord, service gastro-enterologie et hepatologie

    Amiens, 80054

  • ARK Clinical Research (Jean XXIII)

    Angers, 49000

  • ARK Clinical Research (Proust)

    Angers, 49000

  • ARK Clinical Research - Chanzy

    Angers, 49000

  • ARK Clinical Research

    Avrillé, 49000

  • Hopital Avicenne, Centre d'exploitation fonctionnelle et reducation digestive

    Bobigny, 93009

  • Service de Gastroenterologie & INSERM CIC-P 803 - CHU de Dijon

    Dijon, 21079

  • ARK Clinical Research

    Le Plessis-Grammoire, 49124

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Hopital Archet 2- service gastro-enterologie et hepatologie

    Nice, 06002

  • Hôpital Pontchaillou - Service des Maladies de l'Appareil Digestif

    Rennes, 35000

  • Cabinet Médical

    Thouars

  • ARK Clinical Research

    Vendôme, 41100

Other trials in France

Czechia9 sites

  • CCBR Czech Republic Brno

    Brno, 60200

  • KKN a.s.

    Karlovy Vary, 36001

  • CCBR Czech Republic Pardubice

    Pardubice, 530 02

  • Universtiy Hospital Kralovske Vinhorady

    Prague, 100 34

  • MONSE s.r.o.

    Prague, 118 33

  • Hospital Slany

    Slaný, 274 01

  • Orlickoustecka nemocnice

    Ústí nad Orlicí, 562 01

  • Krajska Nemocnice T. Bati a.s., Interni oddeleni - klinika IPVZ; Nemocnicni Lekarna

    Zlín, 762 75

  • Krajska Nemocnice T. Bati a.s.

    Zlín, 762 75

Other trials in Czechia

United Kingdom8 sites

  • Oldfield Surgery

    Bath, BA2 3HT

  • Avondale Surgery

    Chesterfield, S40 4TE

  • University Hospital & Warwickshire -

    Coventry, CV2 2DX

  • County Durham & Darlington NHS Foundation Trust

    Durham, DH1 5GA

  • Burbage Surgery

    Hinckley, LE10 2SE

  • Townhead Research

    Irvine, KA12 0AY

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Sherbourne Medical Centre

    Royal Leamington Spa, CV32 4RA

Other trials in United Kingdom

Netherlands7 sites

  • Meander Medisch Centrum

    Amersfoort, 3818 ES

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • PT&R / PreCare Trial & Recruitment

    Beek, 6191JW

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Maastricht Universitair medisch Centrum

    Maastricht, 6229 HX

  • Erasmus MC

    Rotterdam, 3015 CE

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

Other trials in Netherlands

Poland7 sites

  • Gabinet Lekarski Janusz Rudziński

    Bydgoszcz, 85-681

  • Instytut Medycyny Wsi im. Witolda Chodźki - Zaklad Endoskopowych Badań Kliniczncyh

    Lublin, 20-950

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Chirurgii Ogólnej i Gastroenterologii

    Torun, 87-100

  • Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

    Warsaw, 02-653

  • NZOZ Vivamed

    Warsaw, 03-580

Other trials in Poland

Belgium6 sites

  • Gastro-Kliniek cvba

    Antwerp, 2018

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • GP / Huisartsenpraktijk De Regenboog

    Deurne, 2100

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU Sart Tilman

    Liège, 4000

  • Private Practice

    Wetteren, 9230

Other trials in Belgium

Denmark3 sites

  • CCBR DK Aalborg

    Aalborg, 9000

  • CCBR DK Ballerup

    Ballerup Municipality, 2750

  • CCBR DK Vejle

    Vejle, 7100

Other trials in Denmark

Germany3 sites

  • emovis GmbH

    Berlin, 10629

  • Gastroenterologie und Hepatologie am Johannisplatz

    Leipzig, 04103

  • Fachartzpraxis für Innere Medizin

    Wiesbaden, 65285

Other trials in Germany

Bulgaria1 site

  • 4 MHAT

    Sofia, 1000

Other trials in Bulgaria

About this study

Official title: A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation

This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.

Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.

Read the detailed description

In this phase III trial subjects will be screened and enter a 2-week run-in period (or a 3-week run-in period if the subject is using agents that influence bowel habit) during which the presence of constipation will be confirmed [the subject will complete an electronic daily diary (e-diary)]. At the start of run-in, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative [Dulcolax (bisacodyl)] as rescue medication during the trial, but only if they have not had a bowel movement (BM) for 3 or more consecutive days. An enema can only be used after unsuccessful use of Dulcolax (bisacodyl). No Dulcolax (bisacodyl) should be taken or enemas used between 48 hours before and 48 hours after the first intake of study medication.

After the run-in subjects will be randomly assigned to placebo or prucalopride in an equal ratio (1:1) if the subject fulfils the constipation criteria for inclusion. Randomisation will be stratified by country and by the average number of complete bowel movements (CBM) during run-in: 0 CBM/week and > 0 CBM/week.

Adult subjects (i.e. subjects ≥18 to <65 years of age) will take 2 mg prucalopride or matching placebo once daily before breakfast during the entire 12-week treatment period. Elderly subjects (i.e. subjects ≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo once daily before breakfast. In case of insufficient response, defined as an average of <3 spontaneous complete bowel movements (SCBM)/week during the preceding 2 weeks of treatment (i.e. since the previous visit) at Week 2 or Week 4, the daily dose has to be increased to 2 mg (or matching placebo). Once the dose is increased to 2 mg once daily the subject will stay on this dose for the remainder of the trial. After Week 4 (Visit 4) no changes in dose are allowed anymore.

Being tested
Placebo, Prucalopride
Keywords
Constipation, Male
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo matched to Prucalopride tablet orally once daily.

  • PrucaloprideDrug

    Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.

Study groups in NCT01147926
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
PrucaloprideActive comparator1 milligram (mg) or 2 mg
Receives: Drug: Prucalopride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week

    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.

    Measured: Over 12 week treatment period

Secondary outcomes (13)

  1. Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period

    Measured: Over 12 week treatment period

  2. Percentage of Subjects With an Increase of at Least 1 SCBM Per Week

    Measured: Over 12 week treatment period

  3. SCBM Per Week

    Measured: Over 12 week treatment period

  4. Percent SBM With a Consistency of Normal and Hard/Very Hard

    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.

    Measured: Over 12 week treatment period

  5. Percent SCBM With No Straining and Severe/Very Severe Straining

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

    Measured: Over 12 week treatment period

  6. Percent SBM With Sensation of Complete Evacuation

    Measured: Over 12 week treatment period

  7. Time to First SCBM After Investigational Product Intake on Day 1

    Measured: Day 1

  8. Bisacodyl Tablets Taken Per Week

    Measured: Over 12 week treatment period

  9. Days With Rescue Medication Taken Per Week

    Measured: Over 12 week treatment period

  10. Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment

    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.

    Measured: Over 12 week treatment period

  11. Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment

    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.

    Measured: Over 12 week treatment period

  12. Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment

    Subject was asked to rate the severity of his constipation using a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe

    Measured: Over 12 week treatment period

  13. Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment

    The subject was asked to rate his global evaluation of the efficacy of treatment using the following 5-point scale: 0=not at all effective 1=a little bit effective 2=moderately effective 3=quite a bit effective 4=extremely effective.

    Measured: Over 12 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2010 (estimated)
  2. Study start23 Sep 2010
  3. Primary completion25 Oct 2013
  4. Study completion25 Oct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01147926
Sponsor's protocol ID
SPD555-302
Other IDs
M0001-C302, 2009-015719-42, 2009
Status last verified
May 2021
First submitted
17 Jun 2010
Last updated
10 Jun 2021
Data monitoring committee
No

Publications

  • 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. Ther Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024.

    PubMed 39664231

  • 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

  • Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, Levine A. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation. Am J Gastroenterol. 2015 May;110(5):741-8. doi: 10.1038/ajg.2015.115. Epub 2015 Apr 14.

    PubMed 25869393

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prucalopride in people with Male Subjects With Chronic Constipation, run by Shire at 73 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Romania, France, Czechia, United Kingdom, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week (time frame: Over 12 week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01147926, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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