ConstipationPhase 4SPD555-401NCT01424228
Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
A Phase 4 study testing prucalopride in people with Constipation, run by Shire at 60 sites in 9 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 364 participants
- Where
- 60 sitesin 9 countries
- Study dates
- 6 Apr 2011to 19 Dec 2012
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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.
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
Hungary14 sites
UNO Medical Trials, Kft.
Budapest, 1135
Pannónia Magánorvosi Centrum Kft.
Budapest, 1136
Fundamed Háziorvosi Szövetkezet
Érd, Pest County, 2030
Petz Aladár Megyei Oktató Kórház
Győr, Győr-Moson-Sopron, 9024
Békés Megyei Képviselotestület Pándy Kálmán Kórháza
Gyula, Bekes County, 5700
BAZ Megyei és Egyetemi Oktató Kórház
Miskolc, 3526
Karolina Kórház Rendelointézet
Mosonmagyaróvar, Győr-Moson-Sopron, 9200
Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika
Szeged, Csongrád megye, 6720
Fejér Megyei Szent György Kórház
Székesfehérvár, Pejer, 8000
Clinfan Kft. SMO
Szekszárd, 7100
Dr. Bugyi István Kórház
Szentes, Csongrád megye, 6600
CRU Hungary Kft.
Szikszó, 3800
Bíró Praxis Kft.
Úrhida, 8142
Jávorszky Ödön Városi Kórház
Vác, 2600
Romania11 sites
Spitalul Militar Central Bucuresti
Bucharest, Bucharest, 010825
Centrul Medical Sana
Bucharest, Bucharest, 011025
SC Cabinet Medical Dr. Blaj Stefan SRL
Bucharest, Sector 5, 040101
Endocenter Medicina Integrativa SRL
Bucharest, 021978
Spitalul Clinic Judetean Cluj,Clinica Medicala I
Cluj-Napoca, Cluj, 400006
Biomed Plus SRL
Craiova, Dolj, 200347
Gastromedica SRL
Iași, 700506
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245
CMI de Gastroenterologie Dobru Daniela
Târgu Mureş, 540103
Centrul Medical Tuculanu SRL
Timișoara, Timiș County, 300158
Policlinic Algomed SRL
Timișoara, 300002
Czechia7 sites
Derma Plus s.r.o.
České Budějovice, 370 01
Oblastní nemocnice Kolín, a.s.
Kolín, 280 20
Diagnostika a Lécba Zažívacích Chorob, s.r.o.
Ostrava-Hrabuvka, 700 30
MONSE s.r.o
Prague, 118 33
Fakultní Thomayerova nemocnice s poliklinikou
Praha 4 - Krc, Prague, 140 59
Nemocnice Tábor, a.s.
Tábor, 390 03
Orlickoústecká Nemocnice a.s
Ústí nad Orlicí, 562 18
Italy6 sites
Azienda Ospedale San Martino
Genova, 16132
Policlinico Universitario
Padova, 35128
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Policlinico Universitario Campus Biomedico
Roma, 00128
Azienda Policlinico Umberto I di Roma
Roma, 00161
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Poland6 sites
Centrum Medyczne sw. Lukasza Sp. z o.o.
Częstochowa, Silesian Voivodeship, 42-202
Krakowskie Centrum Medyczne NZOZ
Krakow, Lesser Poland Voivodeship, 31-501
Szpital Wojewódzki w Opolu
Opole, Opole Voivodeship, 45-061
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, 81-756
Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"
Szczecin, West Pomeranian Voivodeship, 70-361
Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
Warsaw, Masovian Voivodeship, 02-653
Slovakia6 sites
Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
Bratislava, 811 07
Gastroenterologická ambulancia
Košice, 040 01
PIGEAS s.r.o.
Martin, 03601
Radvanská lekáren, spol. s r.o.,
Nitra, 950 01
Gastro I.s.r.o.
Prešov, 08001
GEA s.r.o Gastroenterologicka ambulancia
Trnava, 91701
Belgium4 sites
Cliniques Universitaires St. Luc
Brussels, 1200
Huisartspraktijk Jaak Mortelmans
Ham, 3945
Universitaire Ziekenhuizen Leuven
Leuven, Flemish Brabant, 3000
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, 4000
Spain3 sites
Hospital Clínico San Carlos
Madrid, 28040
Hospital Parc Tauli
Sabadell, Barcelona, 08208
Hospital Universitario Nuestra Señora de Valme
Seville, 41014
Sweden3 sites
Sahlgrenska Universitetsjukhuset
Gothenburg, Västra Götaland County, 413 45
Aleris Specialistvård Sabbatsberg
Stockholm, 113 82
Karolinska University Hospital Solna
Stockholm, 171 76
About this study
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
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).
- Conditions
- Constipation
- Being tested
- placebo, prucalopride
- Keywords
- Long term, Constipation, Digestive signs and symptoms
- Medical subject headings
- Constipation, Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
prucaloprideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 2 mg tablet once daily before breakfast Receives: Drug: placebo |
| prucalopride | Active comparator | Prucalopride 2 mg once daily before breakfast Receives: Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Over 24 week treatment period
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
Measured: Over 24 week treatment period
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
Measured: Baseline and Over 24 week treatment period
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
Measured: Over 24 week treatment period
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period
Measured: Over 24 week treatment period
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.
Measured: Baseline and Over 24 week treatment period
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks
Measured: Baseline and Over 24 week treatment period
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)
Measured: Baseline and Over 24 week treatment period
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks
Measured: Baseline and Over 24 week treatment period
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks
Measured: Baseline and Over 24 week treatment period
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28
Measured: Day 1 and 28
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks
Measured: Baseline and Over 24 week treatment period
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.
Measured: Baseline and Over 24 week treatment period
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.
Measured: Baseline and Over 24 week treatment period
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.
Measured: Baseline and Over 24 week treatment period
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.
Measured: Baseline and Over 24 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study start6 Apr 2011
- Primary completion19 Dec 2012
- Study completion19 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424228
- Sponsor's protocol ID
- M0001-C401
- Other IDs
- 2011-000670-62, SPD555-401
- Acronym
- SPD555-401
- Status last verified
- May 2021
- First submitted
- 25 Aug 2011
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 39664231Staller 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 34585675Piessevaux 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01424228
- Acronym / sponsor ID
- SPD555-401 / M0001-C401
- Conditions
- Constipation
- Keywords
- Long term, Constipation, Digestive signs and symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2011 (actual)
- Primary completion
- 19 Dec 2012 (actual)
- Study completion
- 19 Dec 2012 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPlacebo 2 mg tablet once daily before breakfast |
| prucalopride | Active comparator | Drug: prucalopridePrucalopride 2 mg once daily before breakfast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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].
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPlacebo matching tablet 2 mg once daily before breakfast for 24 weeks | Drug | Placebo |
| prucalopridePrucalopride 2 mg daily before breakfast 1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4 | Drug | prucalopride |
Primary outcome
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period
Time frame: Over 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.
16 secondary outcomes
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
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
Time frame: Over 24 week treatment period
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
Time frame: Baseline and Over 24 week treatment period
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
Time frame: Over 24 week treatment period
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
Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks
Time frame: Baseline and Over 24 week treatment period
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
Change From Baseline in Straining Per SCBM at Up to 24 Weeks
Time frame: Baseline and Over 24 week treatment period
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
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
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28
Time frame: Day 1 and 28
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
Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks
Time frame: Baseline and Over 24 week treatment period
Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value
Time frame: Baseline and Over 24 week treatment period
Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value
Time frame: Baseline and Over 24 week treatment period
Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value
Time frame: Baseline and Over 24 week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39664231Lembo 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.
- Derived from this study: PubMed 34585675Staller 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.
- Derived from this study: PubMed 25808103Piessevaux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prucalopride in people with Constipation, run by Shire at 60 sites in 9 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 3 inclusion and 4 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 11 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 60 sites in Hungary, Romania, Czechia, Italy, Poland and 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Apr 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 Over the 24 Week Treatment Period (time frame: Over 24 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 NCT01424228, 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 11 Jun 2021.