Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study
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|ClinicalTrials.gov Identifier: NCT01567956|
Recruitment Status : Terminated (Evidence of very low probability to success. No safety issues)
First Posted : March 30, 2012
Last Update Posted : November 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Propionyl-L-Carnitine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||January 2014|
Modified release tablets containing 500 mg of propionyl-L-carnitine
500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks
Placebo Comparator: Placebo
Modified release tablets containing inert substances
500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks
- 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.
- Change from baseline in Rectal bleeding evaluation [ Time Frame: At week 2, 6 and 8 of treatment and after 4 week follow-up ]Evaluation will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
- Change from baseline in stool frequency evaluation [ Time Frame: At week 2, 6 and 8 of treatment and after 4 week follow-up ]Evaluations will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
- Histological response to the treatment [ Time Frame: End of treatment (week 8) ]Evaluated as an improvement of the histological index of at least 1 point
- 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 ]A validated specific questionnaire, the SIBDQ by McMaster university will be administered to evaluate changes in patients' quality of life
- Haematology [ Time Frame: Baseline and end of treatment (week8) ]Haemoglobin, Haematocrit, RBC, WBC and differential count.
- Electrocardiogram [ Time Frame: At baseline and at the end of treatment period (week8) ]Standard intervals (PR, RR, QRS, QT) will be collected plus all rhythm abnormalities
- Adverse Events collection [ Time Frame: 12 weeks ]
- Serum Chemistry [ Time Frame: At baseline and at the end of treatment period (week8) ]Standard evaluation including renal and liver function, electrolytes and blood glucose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567956
Show 58 Study Locations
|Study Chair:||Sandro Ardizzone, MD||Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY|