Trial Outcomes & Findings for Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury (NCT NCT00597818)

NCT ID: NCT00597818

Last Updated: 2019-12-26

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

121 participants

Primary outcome timeframe

at 20 months

Results posted on

2019-12-26

Participant Flow

Of 124 participants recruited, only 121 were actually enrolled.

Participant milestones

Participant milestones
Measure	Placebo Matching placebo	18 mcg Cobiprostone 18 mcg once daily (QD)	36 mcg Cobiprostone 18 mcg twice daily (BID)	54 mcg Cobiprostone 18 mcg three times daily (TID)
Overall Study STARTED	30	30	31	30
Overall Study COMPLETED	12	14	12	20
Overall Study NOT COMPLETED	18	16	19	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=32 Participants Matching placebo	Cobiprostone QD n=30 Participants Cobiprostone 18 mcg once daily (QD)	Cobiprostone BID n=31 Participants Cobiprostone 18 mcg twice daily (BID)	Cobiprostone TID n=31 Participants Cobiprostone 18 mcg three times daily (TID)	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants	29 Participants n=4 Participants	112 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Age, Continuous	54.1 years STANDARD_DEVIATION 7.9 • n=5 Participants	53.9 years STANDARD_DEVIATION 8.01 • n=7 Participants	54.6 years STANDARD_DEVIATION 8.28 • n=5 Participants	53.3 years STANDARD_DEVIATION 8.18 • n=4 Participants	54.0 years STANDARD_DEVIATION 8.01 • n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	24 Participants n=4 Participants	90 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	34 Participants n=21 Participants
Region of Enrollment United States	32 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	31 Participants n=4 Participants	124 Participants n=21 Participants

PRIMARY outcome

Timeframe: at 20 months

Population: Intention to treat (ITT) population, defined as all participants enrolled in the trial

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Matching placebo	Cobiprostone QD n=30 Participants Cobiprostone 18 mcg once daily (QD)	Cobiprostone BID n=31 Participants Cobiprostone 18 mcg twice daily (BID)	Cobiprostone TID n=30 Participants Cobiprostone 18 mcg three times daily (TID)
Number of Participants With Gastric Ulcers	7 Participants	5 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: at 20 months

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Matching placebo	Cobiprostone QD n=30 Participants Cobiprostone 18 mcg once daily (QD)	Cobiprostone BID n=31 Participants Cobiprostone 18 mcg twice daily (BID)	Cobiprostone TID n=30 Participants Cobiprostone 18 mcg three times daily (TID)
Number of Participants With Duodenal and Gastroduodenal Ulcers	1 Participants	4 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: at Week 4

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Matching placebo	Cobiprostone QD n=30 Participants Cobiprostone 18 mcg once daily (QD)	Cobiprostone BID n=31 Participants Cobiprostone 18 mcg twice daily (BID)	Cobiprostone TID n=30 Participants Cobiprostone 18 mcg three times daily (TID)
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers	7 Participants	8 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: at 20 Months

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Matching placebo	Cobiprostone QD n=30 Participants Cobiprostone 18 mcg once daily (QD)	Cobiprostone BID n=31 Participants Cobiprostone 18 mcg twice daily (BID)	Cobiprostone TID n=30 Participants Cobiprostone 18 mcg three times daily (TID)
Size of Ulcers/Erosions	8.5 mm Standard Deviation 20.49	4.7 mm Standard Deviation 2.63	3.5 mm Standard Deviation 2.35	2.6 mm Standard Deviation 1.54

Adverse Events

Placebo

Serious events: 22 serious events

Other events: 20 other events

Deaths: 0 deaths

Cobiprostone QD

Serious events: 23 serious events

Other events: 18 other events

Deaths: 0 deaths

Cobiprostone BID

Serious events: 25 serious events

Other events: 22 other events

Deaths: 0 deaths

Cobiprostone TID

Serious events: 26 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=30 participants at risk Matching placebo	Cobiprostone QD n=30 participants at risk Cobiprostone 18 mcg once daily (QD)	Cobiprostone BID n=31 participants at risk Cobiprostone 18 mcg twice daily (BID)	Cobiprostone TID n=30 participants at risk Cobiprostone 18 mcg three times daily (TID)
Gastrointestinal disorders Diarrhoea	13.3% 4/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	13.3% 4/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	32.3% 10/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	36.7% 11/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Nausea	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	16.1% 5/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	16.7% 5/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Dyspepsia	16.7% 5/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.2% 1/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	13.3% 4/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Gastritis	13.3% 4/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	13.3% 4/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.5% 2/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Erosive Oesophagitis	16.7% 5/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.5% 2/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Flatulence	13.3% 4/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.2% 1/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Abdominal Pain Other	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	9.7% 3/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Duodenitis	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.2% 1/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Reflux oesphagitis	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	0.00% 0/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.3% 1/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Gastritis erosive	10.0% 3/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.2% 1/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	0.00% 0/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Abdominal distension	3.3% 1/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.2% 1/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.3% 1/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Constipation	0.00% 0/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	0.00% 0/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.2% 1/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months
Gastrointestinal disorders Oesophagitis	6.7% 2/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	0.00% 0/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	0.00% 0/31 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months	3.3% 1/30 • All participants were treated and followed for ulcers and other adverse events for a total of 20 months

Additional Information

Medical Information Call Center

Mallinckrodt Pharmaceuticals

Phone: 800-556-3314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER