Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study
|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
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|