Recruitment

Recruitment Status
Completed
Estimated Enrollment
375

Inclusion Criteria

Signed informed consent,
Presence of significant left lower quadrant pain during the last 24 hours before baseline,
Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
...
Signed informed consent,
Presence of significant left lower quadrant pain during the last 24 hours before baseline,
Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
CRP > ULN and/or leucocytosis (> ULN) at screening visit
Men or women between 18 and 80 years of age,
Patient is eligible for out-patient treatment,

Exclusion Criteria

Active peptic ulcer disease,
Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
Colorectal cancer or a history of colorectal cancer,
...
Active peptic ulcer disease,
Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
Colorectal cancer or a history of colorectal cancer,
Right-sided diverticulitis,
Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
Abnormal hepatic function or liver cirrhosis,
Abnormal renal function,
Hemorrhagic diathesis,
Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),

Summary

Conditions
Uncomplicated Diverticulitis
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Inclusion Criteria

Signed informed consent,
Presence of significant left lower quadrant pain during the last 24 hours before baseline,
Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
...
Signed informed consent,
Presence of significant left lower quadrant pain during the last 24 hours before baseline,
Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
CRP > ULN and/or leucocytosis (> ULN) at screening visit
Men or women between 18 and 80 years of age,
Patient is eligible for out-patient treatment,

Exclusion Criteria

Active peptic ulcer disease,
Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
Colorectal cancer or a history of colorectal cancer,
...
Active peptic ulcer disease,
Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
Colorectal cancer or a history of colorectal cancer,
Right-sided diverticulitis,
Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
Abnormal hepatic function or liver cirrhosis,
Abnormal renal function,
Hemorrhagic diathesis,
Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),

Locations

Cologne, Nordrhein-Westfalen, 51103
Cologne, Nordrhein-Westfalen, 51103

Tracking Information

NCT #
NCT01847664
Collaborators
Not Provided
Investigators
Not Provided