Trial Outcomes & Findings for Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec (NCT NCT00594854)

Last Updated: 2010-09-22

Results Overview

Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2010-09-22

Participant Flow

Multi-center US study, 16 sites recruited subjects between November 2007 and June 2008. On May 2, 2008 POZEN reached agreement with the FDA to terminate the study based on difficulty in recruiting subjects.

Screening for eligibility and wash-out of restricted medications.

Participant milestones

Participant milestones
Measure	PN400 (VIMOVO) PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec diclofenac/misoprostol dosed twice daily (bid)
Overall Study STARTED	9	11
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Reasons for withdrawal
Measure	PN400 (VIMOVO) PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec diclofenac/misoprostol dosed twice daily (bid)
Overall Study Study terminated	7	10

Baseline Characteristics

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PN400 (VIMOVO) n=9 Participants PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec n=11 Participants diclofenac/misoprostol dosed twice daily (bid)	Total n=20 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
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	63.2 years STANDARD_DEVIATION 9.5 • n=5 Participants	54.4 years STANDARD_DEVIATION 17.2 • n=7 Participants	58.4 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.

Outcome measures

Outcome measures
Measure	PN400 (VIMOVO) n=9 Participants PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec n=11 Participants diclofenac/misoprostol dosed twice daily (bid)
Number of Participants With Gastric Ulcer Confirmed by Endoscopy	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Number of participants with duodenal ulcers confirmed by endoscopy following administration of PN 400 VIMOVO)or Arthrotec in a high risk population

Outcome measures

Outcome measures
Measure	PN400 (VIMOVO) n=9 Participants PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec n=11 Participants diclofenac/misoprostol dosed twice daily (bid)
Number of Participants With Duodenal Ulcers Confirmed by Endoscopy	0 participants Interval 0.0 to 33.6	1 participants Interval 0.2 to 41.3

SECONDARY outcome

Timeframe: 6 months

The degree of upper gastrointestinal (UGI) injury as measured by Lanza scores (1991) during treatment with PN 400 and ARTHROTEC® in a high-risk population. The Lanza (1991) score is based on endoscopic obeservations and rating these, with no damage, petecchiae, erosions and ulcers. On the 1991 scale, a Lanza score of 0 represents normal mucosa (no damage), while a score of 4 indicates 6-10 erosions, and a score of 7 indicates an ulcer.

Outcome measures

Outcome measures
Measure	PN400 (VIMOVO) n=9 Participants PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec n=11 Participants diclofenac/misoprostol dosed twice daily (bid)
Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score	2 participants Interval 0.0 to 0.0	2 participants Interval 0.0 to 0.0

Adverse Events

PN400 (VIMOVO)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Arthrotec

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Vice President, Clinical Research

Pozen Inc.

Phone: 919-913-1030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	PN400 (VIMOVO) n=9 participants at risk PN 400 (esomeprazole/naproxen) dosed twice daily (bid)	Arthrotec n=11 participants at risk diclofenac/misoprostol dosed twice daily (bid)
Gastrointestinal disorders Gastritis Erosive	33.3% 3/9 • Number of events 3 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Gastritis	22.2% 2/9 • Number of events 2 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	0.00% 0/11 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Erosive duodenitis	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Flatulence	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	0.00% 0/11 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Abdominal Distension	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Duodenitis	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Hiatus hernia	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Nausea	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	27.3% 3/11 • Number of events 3 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Oesophagitis	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Investigations Haematocrit decreased	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	0.00% 0/11 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Investigations Haemoglobin decreased	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	0.00% 0/11 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Psychiatric disorders Anxiety	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	0.00% 0/11 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Psychiatric disorders Depression	11.1% 1/9 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	0.00% 0/11 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.
Nervous system disorders Migraine	0.00% 0/9 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collection were planned at 1, 3 and 6 months. In May 2008 POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment. No 6 month adverse events data were collected.