Ulcerative ColitisPhase 3NCT01538251
Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis
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
- 147 participants
- Where
- 58 sitesin 8 countries
- Study dates
- Apr 2012to Dec 2013
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
58 sites in 8 countries.
58 sites in 8 countries
Russia12 sites
State Scientific Centre of Coloproctology
Moscow, 123423
State Educational Institution of Higher Professional Education Novosibirsk State Medical University
Novosibirsk, 630091
State Research Institute of Physiology of Siberian Branch of Russian Academy of Medical Sciences
Novosibirsk, 630117
GOU VPO Rostov State Medical University
Rostov-on-Don, 344022
Saint Petersburg GUZ City Policlinic 38
Saint Petersburg, 193015
Regional Military Clinical Hospital ¿ 442 named after Z.P. Solovyov of Ministry of Defence of Russia
Saint Petersburg, 193124
Saint-Petersburg Medical Academy
Saint Petersburg, 195067
Saint-Petersburg State Institution of Health Protection City Hospital # 26
Saint Petersburg, 196247
Krestovsky Medical Institute
Saint Petersburg, 197110
Saratov City Hospital #2
Saratov, 410053
State Educational Institution of Higher Professional Education "Stavropol State Medical Academy"
Stavropol, 355017
Clinical Hospital #2
Yaroslavl, 150010
Czechia9 sites
Derma Plus s.r.o.
České Budějovice, 370 01
Hepato-Gastroenterology HK s.r.o.
Hradec Králové, 500 12
Fakultní nemocnice Olomouc
Olomouc, 775 20
G.E.P. Clinic s.r.o.
Prague, 100 00
MONSE s.r.o
Prague, 118 33
Fakultní Nemocnice v Motole
Prague, 15006
Fakultní Thomayerova nemocnice s poliklinikou
Praha 4 - Krc, 140 59
Nemocnice Tábor, a.s.
Tábor, 390 03
Orlickoústecká Nemocnice a.s
Ústí nad Orlicí, 562 18
Israel8 sites
Soroka University Medical Center
Beersheba, 84100
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah Medical Organization, Ein Kerem
Jerusalem
Meir Medical Center
Kfar Saba, 44281
Rabin Medical Center
Petah Tikva, 49100
Kaplan Medical Center
Rehovot, 76100
Tel Aviv Souraski Medical Center
Tel Aviv, 64239
Assaf Harofeh Medical Centre
Tsrifin, 70300
Slovakia8 sites
NovaMed spol. s.r.o.
Banská Bystrica, 974 01
UNB Nemocnica Staré Mesto
Bratislava, 813 69
ABAWI spol.s.r.o.
Bratislava, 82101
Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
Bratislava, 831 04
Neštátna Gastroenterologická Ambulancia
Bratislava, 851 01
KM Management sro
Nitra, 950 01
Gastro I.s.r.o.
Prešov, 08001
GEA s.r.o Gastroenterologicka ambulancia
Trnava, 91701
Italy7 sites
Ospedale "G.B.Morgagni - L. Pierantoni"
Forlì, Forli-cesena, 47100
Ospedale Luigi Sacco - Az. Osp. Dept. of Gastroenterology
Milan, 20157
Policlinico Universitario Federico II
Naples, 80131
IRCSS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera S. Camillo Forlanini, Roma
Roma, 00152
Policlinico Universitario Agostino Gemelli
Roma, 00168
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Romania7 sites
Neomed Research
Brasov, 500283
Centrul Medical Sana
Bucharest, 011025
Endocenter Medicina Integrativa SRL
Bucharest, 021978
Gastromedica SRL
Iași, 700506
Spitalul Clinic Judetean De Urgenta Sibiu
Sibiu, 550245
CMI de Gastroenterologie Dobru Daniela
Târgu Mureş, Mureș County, 540461
Policlinic Algomed SRL
Timișoara, 300002
Belgium4 sites
Imelda Ziekenhuis
Bonheiden, Antwerpen, 2820
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, 9000
Universitaire Ziekenhuis Gasthuisberg
Leuven, Flemish Brabant, 3000
H. Hartziekenhuis Roeselare-Menen vzw
Roeselare, West-vlaanderen, 8800
Netherlands3 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091 AC
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA
UMC Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: 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, propionyl-l-carnitine
- 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
Modified release tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.
PlaceboDrug
Tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Propionyl-L-carnitine | Experimental | modified release tablets 500 mg Receives: Drug: Propionyl-L-Carnitine |
| Placebo | Placebo comparator | Modified release tablet 500 mg 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
Measured: Baseline and end of treatment (week8)
Electrocardiogram
Measured: At baseline and at the end of treatment period (week8)
Adverse Events collection
Measured: 8 weeks
Serum Chemistry
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 posted24 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionDec 2013
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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandro Ardizzone, MD, Study director, Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538251
- Sponsor's protocol ID
- ST261DM11005
- Other IDs
- 2011-004765-32
- Status last verified
- Nov 2016
- First submitted
- 20 Feb 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
- 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
- NCT01538251
- Acronym / sponsor ID
- ST261DM11005
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, propionyl-l-carnitine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evidence of very low probability to success. No safety issues.
- Enrolment
- 147 participants (actual)
- Lead sponsor
- sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Feb 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 500 mg |
| Placebo | Placebo comparator | Drug: PlaceboModified release tablet 500 mg |
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 (17 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-CarnitineModified release tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day. | Drug | Propionyl-L-carnitine |
| PlaceboTablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day. | 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: 8 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 director
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 17 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 Russia, Czechia, Israel, Slovakia, Italy 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.