Trial Outcomes & Findings for Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease (NCT NCT00609973)

NCT ID: NCT00609973

Last Updated: 2013-05-03

Results Overview

Adverse events (AE) Discontinuation of study drug due to probably study drug related AE

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2013-05-03

Participant Flow

This study was a pilot multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of ciprofloxacin for the prevention of postoperative recurrence in patients with CD. The study was conducted at 6 centers between January 2008 and March 2011. 33 patients were randomized.

There were no significants events pre-assignment

Participant milestones

Measure	Cipro Ciprofloxacin 500 mg bid	Placebo Placebo bid
Overall Study STARTED	17	16
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	Cipro Ciprofloxacin 500 mg bid	Placebo Placebo bid
Overall Study Adverse Event	2	1
Overall Study Protocol Violation	4	3
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease

Baseline characteristics by cohort

Measure	Cipro n=17 Participants Ciprofloxacin 500 mg bid	Placebo n=16 Participants Placebo bid	Total n=33 Participants Total of all reporting groups
Age, Customized	33 Years n=5 Participants	27 Years n=7 Participants	30 Years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Intention to Treat analysis.Adverse events (AE), which were classified as probably or possibly related to the study drug.

Adverse events (AE) Discontinuation of study drug due to probably study drug related AE

Outcome measures

Measure	Cipro n=17 Participants Ciprofloxacin 500 mg bid	Placebo n=16 Participants Placebo bid
Safety and Tolerability of Ciprofloxacin All AE	25 Adverse events	11 Adverse events
Safety and Tolerability of Ciprofloxacin AE probably or possibly related to study drug	9 Adverse events	1 Adverse events
Safety and Tolerability of Ciprofloxacin Participant stops study drug due to AE	4 Adverse events	1 Adverse events

SECONDARY outcome

Timeframe: 6 months

Population: Endoscopy 6 months, Intention-to-Treat analysis, patients not undergoing endoscopy were assumed to have endoscopic recurrence

Outcome measures

Measure	Cipro n=17 Participants Ciprofloxacin 500 mg bid	Placebo n=16 Participants Placebo bid
Endoscopic Recurrence Under Postoperative Treatment With Study Medication at 6 Months	11 participants	11 participants

Adverse Events

Cipro

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cipro n=17 participants at risk Ciprofloxacin 500 mg bid	Placebo n=16 participants at risk Placebo bid
Gastrointestinal disorders Anastomotic leakage	0.00% 0/17	6.2% 1/16 • Number of events 1

Other adverse events

Measure	Cipro n=17 participants at risk Ciprofloxacin 500 mg bid	Placebo n=16 participants at risk Placebo bid
Gastrointestinal disorders Increase of diarrhea	11.8% 2/17 • Number of events 2	0.00% 0/16
Gastrointestinal disorders Abdominal pain	11.8% 2/17 • Number of events 2	6.2% 1/16 • Number of events 1
Musculoskeletal and connective tissue disorders Joint pain	5.9% 1/17 • Number of events 1	12.5% 2/16 • Number of events 2
General disorders Headache	11.8% 2/17 • Number of events 2	0.00% 0/16
General disorders Wound healing problems	5.9% 1/17 • Number of events 1	6.2% 1/16 • Number of events 1
General disorders Urinary tract infection	0.00% 0/17	12.5% 2/16 • Number of events 2
Gastrointestinal disorders Bloating	0.00% 0/17	12.5% 2/16 • Number of events 2

Additional Information

Hans Herfarth

University of North Carolina

Phone: 9199666806

Email: hherf@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place