Out-patients of both sexes with indication for diagnostic flexible rectosigmoidoscopy. MedDRA version: 14.1 Level: LLT Classification code 10016774 Term: Flexible sigmoidoscopy System Organ Class: 100000004848
Conditions
Interventions
Product Name: Methylene Blue enema 0.002%
Product Code: CB-17-03
Pharmaceutical Form: Enema
INN or Proposed INN: methylthioninium chloride
Current Sponsor code: CB-17-01
Other descriptive name: METHYL
Sponsors
Cosmo Technologies Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age: =18 year old; 2.Rectosigmoidoscopy: out-patients with indication for rectosigmoidoscopy; 3.Contraception (both males and females): either sterile subjects or subjects practising at least one reliable method of contraception or females in post-menopausal status for at least 1 year; 4.Informed Consent: signed written informed consent prior to inclusion in the study. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Pregnancy: pregnant or lactating women or at a risk of becoming pregnant; 2.Allergy: known or suspected hypersensitivity to the active principle; history of anaphylaxis to drugs or allergic reactions in general; 3.Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, methaemoglobinemia, any other relevant disease that might interfere with the aim of the study; 4.Comprehension: inability to comprehend the full nature and purpose of the study and unwillingness to co-operate with the investigator and to comply with the requirements of the entire study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the evaluation of the mucosal staining efficacy after single rectal dose of two Methylene Blue enema formulations containing, respectively, 0.002% methylene blue (Formulation A) and 0.02% methylene blue (Formulation B), in patients undergoing a rectosigmoidoscopy for various reasons.;Secondary Objective: Bowel cleansing quality evaluated according to a four-point scoring system after administration of Methylene Blue enema and of the cleansing enema. To collect data about safety and tolerability of the two test Methylene Blue enema formulations. Evaluation of the number of mucosal lesions detected with the two test Methylene Blue enema formulations and of the proportion of subjects with at least one mucosal lesion. ;Primary end point(s): Mucosal staining efficacy of the two test Methylene Blue enema.;Timepoint(s) of evaluation of this end point: Mucosal staining efficacy will be scored during the rectosigmoidoscopy performed on day 1 (Visit 2), according to a subjective four-point scale scoring system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Bowel cleansing quality evaluated according to a four-point scoring system after administration of Methylene Blue enema and of the cleansing enema. Safety and tolerability (treatment emergent adverse events, vital signs (blood pressure, heart rate, peripheral oxygen saturation)) of the two test Methylene Blue enema formulations. Evaluation of the number of mucosal lesions detected and of the proportion of subjects with at least one mucosal lesion. ;Timepoint(s) of evaluation of this end point: Bowel cleansing quality will be scored during the rectosigmoidoscopy performed on day 1 (Visit 2) according to a four-point scoring system. Safety and tolerability will be evaluated prior, during and after the rectosigmoidoscopy. During the rectosigmoidoscopy the Investigator will report the number of detected mucosal lesions. | — |
Countries
Italy
Contacts
Public ContactStudy Management
CROSS S.A.
Outcome results
None listed