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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 August 2017
Main ID:  EUCTR2011-004765-32-BE
Date of registration: 06/12/2011
Prospective Registration: Yes
Primary sponsor: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Public title: Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates
Scientific title: Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis
Date of first enrolment: 10/01/2012
Target sample size: 444
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004765-32
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Czech Republic Italy Netherlands Slovakia
Contacts
Name: Carla Cucco   
Address:  Viale Shakespeare, 47 00144 Rome Italy
Telephone: +39-06-91394322
Email: carla.cucco@sigma-tau.it
Affiliation:  Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Name: Carla Cucco   
Address:  Viale Shakespeare, 47 00144 Rome Italy
Telephone: +39-06-91394322
Email: carla.cucco@sigma-tau.it
Affiliation:  Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Key inclusion & exclusion criteria
Inclusion criteria:

1. Have read the Information for the Patient and signed the Informed Consent Form.
2. Age comprised between 18 and 75 included.
3. Diagnosis of active ulcerative colitis as confirmed endoscopically (pancolonoscopy) and histologically. A new pancolonoscopy is required if documented evidence of having performed it within the previous 12 months is not available. If available, only a new partial colonoscopy for the visualization of the affected part of the colon is required for the evaluation of the baseline DAI score.
4. Rectal bleeding and stool frequency sub-scores have to be evaluated in occasion of the first patient’s screening study visit (on the basis of the patient’s memory of the episodes occurred during the previous two weeks, and considering the worst condition). At this time the rectal bleeding score must be at least 1.
These two sub-scores will be re-evaluated (according to a paper diary recording) during the three days preceding the preparation for the baseline (pre-treatment) partial colonoscopy, to be performed as closest as possible to the conclusion of the screening period.
Sub-scores recorded in occasion of the baseline (pre-treatment) partial colonoscopy will be utilised for the calculation of the baseline Disease Activity Index (DAI) score.
At this time, patients are considered suitable for randomization if they have a Disease Activity index comprised between 3 and 6 inclusive (mild ulcerative colitis), with a rectal bleeding sub-score of at least 1.
5. Stable background oral aminosalycilates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
6. If female, not pregnant or nursing.
7. For women of childbearing potential (WOCBP), willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug.
A WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral ovariectomy) or is not postmenopausal (defined as amenorrhoea >12 consecutive months).
WOCBP should use 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. They must be on a stable regimen, for at least 1 month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, intrauterine device (IUD), or condom and spermicidal agent. The patient will be informed about the results of the pregnancy test and of the allowed method of contraception and its duration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 444
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:

1. Crohn’s disease and indeterminate colitis.
2. Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
3. Use of systemic antibiotics in the last 10 days preceding the screening.
4. Use of systemic NSAIDs on a repeat basis in the last 10 days preceding the screening.
5. 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.
6. Patients previously treated with biological agents have to be excluded, as well as patients treated with immunosuppressants within the last 6 weeks preceding the screening.
7. Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile), Parasites (i.e. Amoebae, Coccidia, Giardia, Helminths)
8. Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator.
9. History of colon resection.
10. Diverticulitis, symptomatic diverticulosis.
11. Active peptic ulcer disease.
12. Proctitis (extent of inflammation < 15 cm from the anus).
13. Bleeding disorders (alterations of the coagulation factors or any concurrent other disease possibly causing digestive apparatus bleeding).
14. Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening.
15. Active or chronic infection(s) or malignancies.
16. Known hypersensitivity to the active ingredient and excipients of the study drug.
17. Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study.
18. Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance.
19. Patients treated with L-carnitine or its esters derivatives during the three months preceding the screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Mild ulcerative colitis
MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
Pharmaceutical Form: Tablet
INN or Proposed INN: Levocarnitine propyl hydrochloride
CAS Number: 119793-66-7
Current Sponsor code: (ST261) Propionyl-L-carnitine
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: Compare the two treatment groups (ST 261 modified release
tablets 1g/die vs. placebo) with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment
Evaluation of safety and tolerability of ST 261
Primary end point(s): The primary endpoint will be the clinical/endoscopic remission defined as a Disease Activity Index at the end of treatment = 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1.
Secondary Objective: Maintenance of remission after four weeks of treatment interruption, the histological changes, the disease symptoms (sub-scores) improvement and the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ).
Timepoint(s) of evaluation of this end point: Disease Activity Index at the end of treatment = 2 with rectal bleeding sub-score = 0 and no other individual sub-score > 1.
Secondary Outcome(s)
Secondary end point(s): Secondary endpoints will be:
• Rectal bleeding evaluation by means of DAI sub-score (from 0 to 3).
• Stool frequency evaluation by means of DAI sub-score (from 0 to 3).
A clinical response for each of these parameters is defined as a sub-score improvement of at least 1 point over baseline.
The histological response to the treatments, defined as an improvement of the Histological Index (HI – see Appendix III) of at least 1 point at the end of the study (a final HI score of =1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point.
The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers.
A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients’ Quality of Life.
The safety and tolerability of the treatments will be investigated through AEs recording, vital signs, ECG and laboratory evaluation.
Timepoint(s) of evaluation of this end point: A clinical response for each of these parameters is defined as a sub-score improvement of at least 1 point over baseline.
The histological response to the treatments, defined as an improvement of the Histological Index (HI – see Appendix III) of at least 1 point at the end of the study (a final HI score of =1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point.
The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers.
A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients’
Secondary ID(s)
ST261-DM-11-005
Source(s) of Monetary Support
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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