Active colonic Crohn's disease MedDRA version: 8.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon)
Conditions
Interventions
Trade Name: Viagra
Pharmaceutical Form: Film-coated tablet
Sponsors
University College London / University College London Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Able to give informed consent 2) Definite diagnosis of colonic Crohn's disease based on radiological, endoscopic and/or histological criteria 3) Moderate-to-severe disease activity, defined as a Crohn's Disease Activity Index (CDAI) score of 220?475 4) Patients on no medication, or having received stable doses of antibiotics, aminosalicylates or nutritional supplements for at least 4 weeks 5) Patients on immunosuppressants (except steroids) must have received a stable dose for at least three months 6) 18 years of age or older 7) Able to comply with trial requirements (drug taking and visits) 8) Negative serum pregnancy test in females of child-bearing potential, who must agree to use an adequate method of contraception for the duration of trial 9) Stool sample negative for pathogenic bacteria, ova and/or parasites, and C. difficile toxin 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Use of steroids within four weeks or infliximab within eight weeks of start of trial medication; use of any trial medication within the preceding 3 months 2) Existing colostomy or ileostomy; current symptoms of bowel obstruction; any other severe concurrent morbidity including bleeding disorders or active upper gastrointestinal peptic ulceration; likely need for hospitalisation during the period of the study 3) Recent stroke or myocardial infarction (within the preceding 6 months), unstable angina pectoris, moderate or severe cardiac failure, uncontrolled arrhythmias, uncontrolled hypertension, QT3 prolongation on ECG, any patient with hypotension or in whom vasodilation is clinically inadvisable 4) Significant hepatic or renal dysfunction (ALT > twice ULN; creatinine > 149 micromol/L) 5) Current use of any phosphodiesterase-5 inhibitor 6) Current use of CYP 3A4 inhibitors (e.g. erythromycin, saquanavir, ketoconazole, itraconazole) 7) Current use of organic nitrates or organic nitrites in any form (e.g. glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil) 8) Alpha-blocker therapy, unless stable dose for at least 1 month 9) Prior episode non-arteritic anterior ischaemic optic neuropathy 10) Previous adverse reaction to any phosphodiesterase-5 inhibitor 11) Women who are currently or attempting to become pregnant, or those who are breast-feeding 12) Male patients with anatomical deformation of the penis or predisposition to prolonged erection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the Sildenafil-induced improvement in forearm blood flow demonstrated in patients with moderate to severe colonic Crohn’s disease translates into clinical benefits in patients with active disease.;Secondary Objective: To determine whether orally administered Sildenafil citrate induces remission (absolute CDAI </=150) and reduces the endoscopic index of inflammation (Rutgeerts’ score) and histopathological grading of severity in patients with moderate to severe colonic Crohn's disease. To determine the effects of orally administered sildenafil citrate on colonic mucosal blood blow level, plasma neutrophil and white cell count, platelet count, erythrocyte sedimentation rate, serum C-reactive protein level and faecal calprotectin levels after a six week treatment period compared with baseline. ;Primary end point(s): The primary endpoint will be the proportion of patients experiencing a 100 point fall in the Crohn's disease activity index (CDAI score) at Week 6 (end of treatment) compared to baseline. | — |
Countries
United Kingdom
Outcome results
None listed