Clinical trial · Interventional
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
NCT01694966CI-TRIAL-00030202completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylene Blue MMX® | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Methylene Blue MMX® 200mg
- description
- Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
- interventionNames
- Drug: Methylene Blue MMX®
- type
- ACTIVE_COMPARATOR
- label
- Methylene Blue MMX® 100mg
- description
- Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
- interventionNames
- Drug: Methylene Blue MMX®
- Drug: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females, aged between 50 and 75. * Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer ) * Able to comprehend the full nature and purpose of the study, including possible risks and side effects. * Able to co-operate with the investigator and to comply with the requirements of the entire study. * Signed written informed consent prior to inclusion in the study. Exclusion Criteria: * Patients at high risk of colorectal cancer e.g. ulcerative colitis * Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients. * Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients. * Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
References
Publications (1)
- DERIVEDRepici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10. PMID 30742834