Diverticulitis MedDRA version: 9.1 Level: LLT Classification code 10013538 Term: Diverticulitis
Conditions
Interventions
Product Name: 1500 mg mesalazine granules
Pharmaceutical Form: Granules
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Man or woman between 40 and 80 years of age 3. Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography 4. Presence of at least one diverticulum of the left colon 5. Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months (Response: normalization of clinical and biochemical parameters) 6. Most recent attack of left-sided uncomplicated diverticulitis documented by medical records 7. 3 or more of the following symptoms documented at the start of the most recent attack: - left lower quadrant pain - fever (higher than 38 °C by rectal measurement) - altered bowel habit (diarrhea, constipation, passage of mucus, or urgency) - systemic upset (nausea, lethargy) 8. CRP > ULN or leucocytosis (> 10 000/mm³) at the start of the most recent attack 9. Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the patient has adequate birth control for study participation. 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 ;Inclusion criteria: 1. Signed informed consent 2. Man or woman between 40 and 80 years of age 3. Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography 4. Presence of at least one diverticulum of the left colon 5. Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months (Response: normalization of clinical and biochemical parameters) 6. Most recent attack of left-sided uncomplicated diverticulitis documented by medical records 7. 3 or more of the following symptoms documented at the start of the most recent attack: - left lower quadrant pain - fever (higher than 38 °C by rectal measurement) - altered bowel habit (diarrhea, constipation, passage of mucus, or urgency) - systemic upset (nausea, lethargy) 8. CRP > ULN or leucocytosis (> 10 000/mm³) at the start of the most recent attack 9. Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the patient has adequate birth control for study participation. 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. Chronic inflammatory bowel disease (such as Crohn’s disease, ulcerative colitis) 2. Complicated diverticular disease (diverticulitis with associated abscess, fistula, obstruction or perforation); diverticular abscess to be excluded by computed tomography 3. Right-sided diverticulitis 4. Previous colonic surgery (except previous appendectomy, haemorrhoidectomy, and colonic removal of polyps) 5. Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia) 6. Active colorectal cancer or a history of colorectal cancer 7. Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible. 8. Hemorrhagic diathesis 9. Active peptic ulcer disease, local intestinal infection 10. Asthma if careful medical monitoring is not ensured 11. Abnormal hepatic function or liver cirrhosis (ALT, AST or AP = 2 x ULN) 12. Abnormal renal function (Cystatin C, creatinine > ULN) 13. Severe co-morbidity and/or immobility 14. 5-aminosalicylic acid (5-ASA, mesalazine) containing drugs, glucocorticosteroids, opioid analgesics, laxatives, antidiarrheals, immunosuppressants, or non-steroidal anti-inflammatory drug (NSAIDs; as permanent treatment) since most recent attack of uncomplicated diverticulitis; acetylsalicylic acid (= 100 mg/day) or paracetamol allowed 15. Baseline stool positive for organisms causing bowel disease 16. Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile 17. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs 18. Existing or intended pregnancy or breast-feeding 19. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial 20. Only patients planned for CT: hyperthyroidism, history of hypersensitivity to iodine or iodinated contrast media, congestive heart failure (NYHA III/IV), multiple myeloma, diabetes with need of drug treatment ;Exclusion criteria: 1. Chronic inflammatory bowel disease (such as Crohn’s disease, ulcerative colitis) 2. Complicated diverticular disease (diverticulitis with associated abscess, fistula, obstruction or perforation); diverticular abscess to be excluded by computed tomography 3. Right-sided diverticulitis 4. Previous colonic surgery (except previous appendectomy, haemorrhoidectomy, and colonic removal of polyps) 5. Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia) 6. Active colorectal cancer or a history of colorectal cancer 7. Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible. 8. Hemorrhagic diathesis 9. Active peptic ulcer disease, local intestinal infection 10. Asthma if careful medical monitoring is not ensured 11. Abnormal hepatic function or liver cirrhosis (ALT, AST or AP = 2 x ULN) 12. Abnormal renal function (Cystatin C, creatinine > ULN) 13. Severe co-morbidity and/or immobility 14. 5-aminosalicylic acid (5-ASA, mesalazine) containing drugs, glucocorticosteroids, opioid analgesics, laxatives, antidiarrheals, immunosuppressants, or non-steroidal anti-inflammatory drug (NSAIDs; as permanent treatment) since most recent attack of uncomplicated diverticulitis; acetylsalicylic acid (= 100 mg/day) or paracetamol allowed 15. Baseline stool positive for organisms causing bowel disease 16. Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile 17. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs 18. Existing or intended pregnancy or breast-feeding 19. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial 20. Only patients planned for CT: hyperthyroidism, history of hypersensitivity to iodine or iodinated contrast media, congestive heart failure (NYHA III/IV), multiple myeloma, diabetes with need of drug treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To compare the efficacy and tolerability of mesalazine granules (3 g 5-ASA/d) vs. placebo for the prevention of recurrence of diverticulitis -To study safety and tolerability in the form of adverse events and laboratory parameters -To assess patients’ quality of life ;Secondary Objective: -Proportion of patients with recurrence, -Time in study, - " in remission, - " to recurrence, - " to recurrence or discontinuation, -Subgroup analysis for No. of episodes of diverticulitis in the previous year (2 episodes vs >2 episodes), -Subgroup analysis for prompt vs delayed start of treatment after attack, -Subgroup analysis for inflammatory markers increased vs not increased at baseline, -Course of ESR, - " of CRP, - " of leucocytosis, -Occurrence of diverticulitis-associated fever, Number of days with - left lower quadrant pain, - stools of solid consistency, - stools of soft or solid consistency, - diarrhoea (> 3 stools per day), - stools of watery consistency, - Average frequency of stools per week, - Amount of used spasmolytics, - Amount of used analgesics, - Worsening of symptoms, e.g., use of antibiotics, hospitalisation for underlying disease, surgery, - Quality of life, - Health assessment, - Assessment of efficacy by investigator and patient.;Primary end point(s): Proportion of recurrence-free patients within 48 weeks: Recurrence of diverticulitis, defined as CRP > ULN or leucocytosis and recurrence of diverticulitis-like symptoms (left lower quadrant pain, fever) with associated clinical, biochemical parameters or confirmation by ultrasonography or computed tomography.;Main Objective: -To compare the efficacy and tolerability of mesalazine granules (3 g 5-ASA/d) vs. placebo for the prevention of recurrence of diverticulitis -To study safety and tolerability in the form of adverse events and laboratory parameters -To assess patients’ quality of life ;Secondary Objective: -Proportion of patients with recurrence, -Time in study, - " in remission, | — |
Countries
Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Netherlands, Poland, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed