Trial Outcomes & Findings for Citalopram in Irritable Bowel Syndrome (NCT NCT00477165)

NCT ID: NCT00477165

Last Updated: 2017-04-17

Results Overview

Participants were asked weekly to answer subjectively whether weekly adequate relief from IBS symptoms was achieved. Overall response was defined as having achieved adequate relief in at least 3 of the past 6 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: Baseline, weekly for 8 weeks
• Results posted on: 2017-04-17

Participant Flow

A total of 234 potentially eligible subjects were identified. Of these, 180 were excluded and 54 enrolled in the study, with 27 each randomized to citalopram and placebo.

Participant milestones

Measure	Cialopram One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Overall Study STARTED	27	27
Overall Study COMPLETED	20	25
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Measure	Cialopram One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Overall Study Adverse Event	7	2

Baseline Characteristics

Citalopram in Irritable Bowel Syndrome

Baseline characteristics by cohort

Measure	Cialopram n=27 Participants One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo n=27 Participants Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks	Total n=54 Participants Total of all reporting groups
Age, Continuous	53 years n=93 Participants	51 years n=4 Participants	52 years n=27 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	23 Participants n=4 Participants	44 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment United States	27 participants n=93 Participants	27 participants n=4 Participants	54 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, weekly for 8 weeks

Participants were asked weekly to answer subjectively whether weekly adequate relief from IBS symptoms was achieved. Overall response was defined as having achieved adequate relief in at least 3 of the past 6 weeks.

Outcome measures

Measure	Citalopram n=27 Participants One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo n=27 Participants Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Count of Participants Who Self-reported "Adequate Relief"	12 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline; Week 8

The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL consists of 34 statements about bowel problems, each with a five-point response scale ranging from 1 (no problems) to 5 (most problems). The individual scores are summed and averaged for a total score, then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life.

Outcome measures

Measure	Citalopram n=27 Participants One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo n=27 Participants Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Change From Baseline in IBS-QOL Score at Week 8	6.3 units on a scale Interval -0.07 to 12.7	7.6 units on a scale Interval 2.4 to 12.9

SECONDARY outcome

Timeframe: Week 8

Population: Participants with available data were included in the analysis.

A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated sensation 30 seconds into each inflation. Sensation score scale: 0=no inflation sensation, 1-5=increasing painless sensation, 6=threshold pain, 10=worst imaginable pain.

Outcome measures

Measure	Citalopram n=20 Participants One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo n=25 Participants Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Mean Sensation Score as a Function of Distending Pressure at the End of the Study Distending pressure 12mmHg	1 units on a scale Interval 1.0 to 2.0	2 units on a scale Interval 2.0 to 3.0
Mean Sensation Score as a Function of Distending Pressure at the End of the Study Distending pressure 24mmHg	4 units on a scale Interval 3.0 to 5.0	6 units on a scale Interval 3.0 to 6.0
Mean Sensation Score as a Function of Distending Pressure at the End of the Study Distending pressure 36mmHg	5 units on a scale Interval 4.0 to 7.0	7 units on a scale Interval 5.0 to 9.0
Mean Sensation Score as a Function of Distending Pressure at the End of the Study Distending pressure 48mmHg	7 units on a scale Interval 5.0 to 8.0	6 units on a scale Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: Week 8

Population: Participants with available data were included in the analysis.

A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated urgency for bowel movement 30 seconds into each inflation. Urgency score scale: 0=no urgency, 1=threshold urgency, 5=worst imaginable urgency.

Outcome measures

Measure	Citalopram n=20 Participants One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo n=25 Participants Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Urgency Score as a Function of Distending Pressure at the End of the Study Distending pressure 12mmHg	1 units on a scale Interval 1.0 to 2.0	2 units on a scale Interval 1.0 to 2.0
Urgency Score as a Function of Distending Pressure at the End of the Study Distending pressure 24mmHg	4 units on a scale Interval 3.0 to 4.0	5 units on a scale Interval 4.0 to 5.0
Urgency Score as a Function of Distending Pressure at the End of the Study Distending pressure 36mmHg	4 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 4.0 to 5.0
Urgency Score as a Function of Distending Pressure at the End of the Study Distending pressure 48mmHg	5 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 4.0 to 5.0

Adverse Events

Citalopram

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Citalopram n=27 participants at risk One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks	Placebo n=27 participants at risk Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
General disorders Fatigue	11.1% 3/27 • Number of events 3 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
General disorders Insomnia	3.7% 1/27 • Number of events 2 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
Gastrointestinal disorders Diarrhea	3.7% 1/27 • Number of events 1 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Number of events 1 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
Reproductive system and breast disorders Sexual dysfunction	3.7% 1/27 • Number of events 1 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
Psychiatric disorders Somnolence	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	3.7% 1/27 • Number of events 1 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/27 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.	3.7% 1/27 • Number of events 1 • 8 weeks During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.

Additional Information

Uri Ladabaum, MD, MS

Stanford University

Email: ladabau@stanford.edu

Results disclosure agreements

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