Phase 2
N=114
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
Colon Staining in Preparation for Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03287219 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Evaluation of Mucosal Staining Efficacy — 6.8; 2.3; 8.1; 7.0 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylene Blue MMX 25 mg modified release tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cosmo Technologies Ltd
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Mucosal Staining Efficacy |
6.8; 2.3; 8.1; 7.0; 9.8; 10.5 | — |
| SECONDARY Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure) |
122.6; 124.3; 122.6; 124.3; 122.7; 124.2 | — |
| SECONDARY Safety and Tolerability of Methylene Blue MMX as Determined by AEs |
3; 3; 0; 0; 0; 0 | — |
| SECONDARY Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate |
73.9; 75.2; 74.3; 75.3; 74.2; 7.1 | — |
| SECONDARY Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood) |
98.4; 98.7; 98.4; 98.8; 98.4; 98.8 | — |
| SECONDARY Safety and Tolerability of Methylene Blue MMX as Determined Body Weight. |
67.2; 71.3; 67.4; 71.2 | — |
| SECONDARY Bowel Cleansing Quality-Boston Bowel Preparation Score |
5.4; 5.4; 5.4 | — |
Summary
To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.
Eligibility Criteria
Inclusion Criteria
- Sex: males and females;
- Age:18 to 70 years;
- Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
- Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
- Informed Consent: signed written informed consent prior to inclusion in the study.
Exclusion Criteria
- Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
- Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
- Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, inflammatory bowel diseases in active phase, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other relevant disease that might interfere with the aim of the study.
- 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.
Data sourced from ClinicalTrials.gov (NCT03287219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.