ulcerative colitis - inflammation of colon
Conditions
Interventions
See "Description and assessment of strain and risk"
Sponsors
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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.
Exclusion criteria
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), Parasites (i.e. Amoebae, Coccidia, Giardia, Helminths) or toxins (C.difficile).
 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the clinical/endoscopic remission defined as a Disease Activity Index at the end of treatment 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 smaller of equal to 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. | — |
Countries
Netherlands
Outcome results
None listed