Ulcerative ColitisPhase 3NCT01567956
Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study
A Phase 3 study testing Propionyl-L-Carnitine in people with Ulcerative Colitis, run by sigma-tau i.f.r. S.p.A. at 58 sites in 8 countries.
Trial summary
The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Propionyl-L-Carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 58 sitesin 8 countries
- Study dates
- Apr 2012to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have read the Information for the Patient and signed the Informed Consent Form.
- Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically and histologically.
- Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1.
- Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
- If female, not pregnant or nursing. For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug and utilization of an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication.
Who cannot join
- Crohn's disease and indeterminate colitis.
- Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
- Use of systemic antibiotics in the last 10 days preceding the screening.
- Use of systemic Nonsteroidal anti-inflammatory drugs on a repeat basis in the last 10 days preceding the screening.
- Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study.
- Use of immunosuppressants or biological agents within the last 6 weeks preceding the screening.
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- Treatment with L-carnitine or its esters derivatives within the last 3 months.
- Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile).
- Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator.
- History of colon resection.
- Diverticulitis, symptomatic diverticulosis.
- Active peptic ulcer disease.
- Proctitis (extent of inflammation < 15 cm from the anus).
- Bleeding disorders
- Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening.
- Active or chronic infection(s) or malignancies.
- Known hypersensitivity to the active ingredient and excipients of the study drug
- Patients treated with L-Carnitine or its esters derivatives during the 3 months preceding the screening phase.
Trial locations and contacts
58 sites in 8 countries.
58 sites in 8 countries
Germany11 sites
Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik
Berlin, 10117
Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56
Bochum, 44791
Klinikum Braunschweig
Braunschweig, 38126
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
Dresden, 01307
Universtätsklinikum Schleswig-Holstein Gastroenterologie
Lübeck, 23538
Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie
Magdeburg, 39120
Universitätsmedizin Mannheim II. Medizinische Klinik
Mannheim, 68167
Praxis Prof. Dr. med. Herbert Kellner
München, 80639
Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin
Münster, 48149
Gastroenterologische Fachpraxis am Germania Campus
Münster, 48159
Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology
Stade, 21682
Hungary10 sites
Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház
Budapest, 1076
Semmelweis Egyetem 1st Internal Dept.
Budapest, 1083
Pannónia Magánorvosi Centrum Kft.
Budapest, 1136
Semmelweis Egyetem II. sz. Belgyógyászati Klinika
Budapest, H-1088
Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1
Gyula, 5700
Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály
Kaposvár, H-7400
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály
Miskolc, 3526
Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály
Mosonmagyaróvar, 9200
Clinfan Kft. SMO
Szekszárd, 7100
CRU Hungary Kft.
Szikszó, 3800
France9 sites
Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun
Créteil, 94010
Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie
Marseille, 13015
Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie
Nantes, 44000
Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif
Nice, 06202
Hôpital Nord - Dept. of Gastroenterology
Picardie, 80 054
Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie
Reims, 51092
Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
Saint-Etienne, 42270
Hôpital Rangueil Service de gastro-enterologie
Toulouse, 31079
Hôpital Brabois Service de gastro-enterologie
Vandœuvre-lès-Nancy, 54511
Poland9 sites
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J
Ksawerów, 95-054
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej
Lódz, 90-153
Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii
Olsztyn, 10-561
Endoskopia Sp. z o.o.
Sopot, 81-756
Nzoz Vivamed
Warsaw, 03-580
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii
Wroclaw, 50-556
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii
Wroclaw, 51-149
LexMedica
Wroclaw, 53-025
ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew
Wroclaw, 53-333
Spain7 sites
Fundación Hospital de Alcorcón Servicio de Gastroenterología
Alcorcón, 28922
Centro Medico Teknon Servicio de Aparato Disgestivo
Barcelona, 08022
Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo
El Palmar, 30120
Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia
Madrid, 28006
Hospital Universitario La Paz Servico de Gastroenterologia
Madrid, 28046
Corporació Sanitaria Parc Taulí Servicio de Digestivo
Sabadell, 08028
Hospital Universitario Marques de Valdecilla Servicio de Digestivo
Santander, 39008
Austria4 sites
Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie
Innsbruck, 6020
Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin
Salzburg, 5010
Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III
Vienna, 1090
Ordinationszentrum Döbling
Vienna, 1190
Latvia4 sites
Daugavpils Central Regional Hospital
Daugavpils, LV-5400
Paula Stradina Clinical University Hospital Gastroenterology Centre
Riga, LV-1002
Latvian Maritime Medicine Centre
Riga, LV-1005
Digestive Disease Center GASTRO
Riga, LV-1006
Lithuania4 sites
Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius
Kaunas, LT-50009
Klaipedos jurininku ligonine Diagnostikos skyrius
Klaipėda, LT-92288
VšI Mykolo Marcinkeviciaus ligonines
Vilnius, LT-03215
Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras
Vilnius, LT-08661
About this study
Official title: Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment
The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.
Read the detailed description
Although it seems clear that an abnormal function of the colonic epithelium is the central problem causing inflammation and the unusual immunological response to the normal gut flora in inflammatory bowel disease (IBD), the actual causes of these dysfunctions are still unknown. Short Chain Fatty Acids (SCFA) are the main fuel of the colonic epithelium, and are normally produced by the bacterial flora by fermentation of the complex carbohydrates forming non soluble fibers usually introduced with everyday diet. Butyrate alone contributes 70% of the normal colonocyte energy. Studies done using animal models and colonic mucosa biopsies from patients suffering form ulcerative colitis (UC) have consistently shown that a metabolic change occurs in diseased colonic mucosa, with an impairment of butyrate oxidation (and of beta-oxidation) and an energy shortage that is only incompletely compensated by oxidation of glucose and other substrates such as glutamine. It is also well known that matrix metalloproteases production is highly increased in IBD and that serum transglutaminase activity is significantly reduced in patients with IBD. Transglutaminases are enzymes contributing to the crosslinking of matrix proteins and the reduction seen in patients affected by IBD correlates well with the endoscopic and histopathologic grading in UC, meaning that part of the circulating enzyme is sequestered in the injured colonic tissue in the effort to re-build the extracellular matrix during the healing process. Propionyl-L-carnitine Hydrochloride (PLC) is a molecule that has already been shown to reduce membrane lipid peroxidation in endothelial cells from bovine aorta and coronary vessels, to reduce the effects of hypoxia in coronary endothelial cells, and to play a role in the cardiac metabolic abnormalities that contribute to the mechanical dysfunctions leading to heart failure. Given these properties of Propionyl-L-carnitine Hydrochloride (ST 261) and given the peroxidative damage suffered by colonocytes in UC together with their metabolic impairment, the use of this molecule for the treatment of UC seemed to be appropriate and sound, in particular as a carrier of a propionate moiety that, once transformed into succinate, enters the Kreb cycle, acting as an extra burst fuel improving the balance of energy production inside tissues. Previous clinical experience has shown that PLC promoted complete or nearly complete regression of cutaneous trophic ulcers in a large number of vasculopathic patients refractory to all other therapies. As far as the UC pathology is concerned, the effects of ST 261, given orally or intrarectally, were investigated at different dosages, in preclinical experimentation, either after a single trinitrobenzene sulphonic acid (TNBS) administration (acute colitis) or after repeated TNBS administrations (reactivated colitis). The results showed a reduction in the damaged colon area both in acute model and reactivated colitis, even if the beneficial effect of restoration of TNBS-induced alterations of tissue morphology is more evident in the reactivated colitis model, particularly after oral administration. Based on the above-described results a development plan in humans started to investigate the activity of PLC in the treatment of ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Propionyl-L-Carnitine, Placebo
- Keywords
- Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionyl-L-CarnitineDrug
500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks
PlaceboDrug
500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Propionyl-L-Carnitine | Experimental | Modified release tablets containing 500 mg of propionyl-L-carnitine Receives: Drug: Propionyl-L-Carnitine |
| Placebo | Placebo comparator | Modified release tablets containing inert substances Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinical/endoscopic remissions
Remission will be defined according with the overall modified Mayo score (Disease Activity Index). A score ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1 will be considered necessary to classify the patient in remission state.
Measured: End of treatment (week 8)
Secondary outcomes (9)
Change from baseline in Rectal bleeding evaluation
Evaluation will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
Measured: At week 2, 6 and 8 of treatment and after 4 week follow-up
Change from baseline in stool frequency evaluation
Evaluations will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
Measured: At week 2, 6 and 8 of treatment and after 4 week follow-up
Histological response to the treatment
Evaluated as an improvement of the histological index of at least 1 point
Measured: End of treatment (week 8)
Change from baseline in C-reactive protein (CRP) and Fibrinogen
Measured: End of the treatment (week 8) and after 4 week follow-up
Improvement of patients quality of life
A validated specific questionnaire, the SIBDQ by McMaster university will be administered to evaluate changes in patients' quality of life
Measured: End of treatment period (week8) and after 4 week follow-up
Haematology
Haemoglobin, Haematocrit, RBC, WBC and differential count.
Measured: Baseline and end of treatment (week8)
Electrocardiogram
Standard intervals (PR, RR, QRS, QT) will be collected plus all rhythm abnormalities
Measured: At baseline and at the end of treatment period (week8)
Adverse Events collection
Measured: 12 weeks
Serum Chemistry
Standard evaluation including renal and liver function, electrolytes and blood glucose
Measured: At baseline and at the end of treatment period (week8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionJan 2014
Why it stopped: Evidence of very low probability to success. No safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Sandro Ardizzone, MD, Study chair, Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567956
- Sponsor's protocol ID
- ST261DM11006
- Other IDs
- 2011-004770-28
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2012
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment
- ClinicalTrials.gov ID
- NCT01567956
- Acronym / sponsor ID
- ST261DM11006
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evidence of very low probability to success. No safety issues
- Enrolment
- 150 participants (actual)
- Lead sponsor
- sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.
Detailed description
Although it seems clear that an abnormal function of the colonic epithelium is the central problem causing inflammation and the unusual immunological response to the normal gut flora in inflammatory bowel disease (IBD), the actual causes of these dysfunctions are still unknown. Short Chain Fatty Acids (SCFA) are the main fuel of the colonic epithelium, and are normally produced by the bacterial flora by fermentation of the complex carbohydrates forming non soluble fibers usually introduced with everyday diet. Butyrate alone contributes 70% of the normal colonocyte energy. Studies done using animal models and colonic mucosa biopsies from patients suffering form ulcerative colitis (UC) have consistently shown that a metabolic change occurs in diseased colonic mucosa, with an impairment of butyrate oxidation (and of beta-oxidation) and an energy shortage that is only incompletely compensated by oxidation of glucose and other substrates such as glutamine. It is also well known that matrix metalloproteases production is highly increased in IBD and that serum transglutaminase activity is significantly reduced in patients with IBD. Transglutaminases are enzymes contributing to the crosslinking of matrix proteins and the reduction seen in patients affected by IBD correlates well with the endoscopic and histopathologic grading in UC, meaning that part of the circulating enzyme is sequestered in the injured colonic tissue in the effort to re-build the extracellular matrix during the healing process. Propionyl-L-carnitine Hydrochloride (PLC) is a molecule that has already been shown to reduce membrane lipid peroxidation in endothelial cells from bovine aorta and coronary vessels, to reduce the effects of hypoxia in coronary endothelial cells, and to play a role in the cardiac metabolic abnormalities that contribute to the mechanical dysfunctions leading to heart failure. Given these properties of Propionyl-L-carnitine Hydrochloride (ST 261) and given the peroxidative damage suffered by colonocytes in UC together with their metabolic impairment, the use of this molecule for the treatment of UC seemed to be appropriate and sound, in particular as a carrier of a propionate moiety that, once transformed into succinate, enters the Kreb cycle, acting as an extra burst fuel improving the balance of energy production inside tissues. Previous clinical experience has shown that PLC promoted complete or nearly complete regression of cutaneous trophic ulcers in a large number of vasculopathic patients refractory to all other therapies. As far as the UC pathology is concerned, the effects of ST 261, given orally or intrarectally, were investigated at different dosages, in preclinical experimentation, either after a single trinitrobenzene sulphonic acid (TNBS) administration (acute colitis) or after repeated TNBS administrations (reactivated colitis). The results showed a reduction in the damaged colon area both in acute model and reactivated colitis, even if the beneficial effect of restoration of TNBS-induced alterations of tissue morphology is more evident in the reactivated colitis model, particularly after oral administration. Based on the above-described results a development plan in humans started to investigate the activity of PLC in the treatment of ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propionyl-L-Carnitine | Experimental | Drug: Propionyl-L-CarnitineModified release tablets containing 500 mg of propionyl-L-carnitine |
| Placebo | Placebo comparator | Drug: PlaceboModified release tablets containing inert substances |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have read the Information for the Patient and signed the Informed Consent Form.
- Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically and histologically.
- Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1.
- Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
- If female, not pregnant or nursing. For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug and utilization of an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication.
Key exclusion criteria (18 listed)
- Crohn's disease and indeterminate colitis.
- Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
- Use of systemic antibiotics in the last 10 days preceding the screening.
- Use of systemic Nonsteroidal anti-inflammatory drugs on a repeat basis in the last 10 days preceding the screening.
- Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study.
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 |
|---|---|---|
| Propionyl-L-Carnitine500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks | Drug | Propionyl-L-Carnitine |
| Placebo500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks | Drug | Placebo |
Primary outcome
Proportion of clinical/endoscopic remissions
Time frame: End of treatment (week 8)
Remission will be defined according with the overall modified Mayo score (Disease Activity Index). A score ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1 will be considered necessary to classify the patient in remission state.
9 secondary outcomes
Change from baseline in Rectal bleeding evaluation
Time frame: At week 2, 6 and 8 of treatment and after 4 week follow-up
Change from baseline in stool frequency evaluation
Time frame: At week 2, 6 and 8 of treatment and after 4 week follow-up
Histological response to the treatment
Time frame: End of treatment (week 8)
Change from baseline in C-reactive protein (CRP) and Fibrinogen
Time frame: End of the treatment (week 8) and after 4 week follow-up
Improvement of patients quality of life
Time frame: End of treatment period (week8) and after 4 week follow-up
Haematology
Time frame: Baseline and end of treatment (week8)
Electrocardiogram
Time frame: At baseline and at the end of treatment period (week8)
Adverse Events collection
Time frame: 12 weeks
Serum Chemistry
Time frame: At baseline and at the end of treatment period (week8)
Results and safety
The study was stopped early (reason given: Evidence of very low probability to success. No safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Sandro Ardizzone, MD study chair
Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY
58 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propionyl-L-Carnitine in people with Ulcerative Colitis, run by sigma-tau i.f.r. S.p.A. at 58 sites in 8 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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Germany, Hungary, France, Poland, Spain and 3 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?
The study was stopped early (reason given: Evidence of very low probability to success. No safety issues). Results are not available in the source record.
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?
Proportion of clinical/endoscopic remissions (time frame: End of treatment (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2016.