Trial Outcomes & Findings for Viokase 16, Viokase16 Plus Nexium and Nexium Alone (NCT NCT01142128)

NCT ID: NCT01142128

Last Updated: 2013-02-21

Results Overview

To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2013-02-21

Participant Flow

The dates of the recruitment period were February 2009 through January 2010. Subjects recruited at the University of Florida and the Shands Hospital. Recruited a total of 12 subjects. Enrollment was slow due to subjects not wanting to come off their medications, this was unanticipated.

A total of 12 participants were consented to the study, however, 4 participants were never randomized to the study. Prior to randomization, subjects were off all enzymes and proton pump inhibitor's (PPI's) for 14 days.

Participant milestones

Measure	All Participants Participants received one of four interventions in a randomized crossover design: 1. Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium 2. Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium 3. Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium 4. Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
Overall Study STARTED	8
Overall Study Nexium Alone	3
Overall Study Placebo to Nexium, Alone	3
Overall Study Viokase 16 Plus Nexium	2
Overall Study Viokase 16 Plus Placebo to Nexium	0
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	All Participants Participants received one of four interventions in a randomized crossover design: 1. Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium 2. Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium 3. Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium 4. Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Baseline characteristics by cohort

Measure	Nexium Alone n=3 Participants Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium	Placebo to Nexium, Alone n=3 Participants Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium	Viokase 16 Plus Nexium n=2 Participants Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium	Viokase 16 Plus Placebo to Nexium Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone	Total n=8 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=21 Participants
Age Categorical Between 18 and 65 years	3 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	—	7 participants n=21 Participants
Age Categorical >=65 years	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	—	1 participants n=21 Participants
Gender Female	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	—	4 participants n=21 Participants
Gender Male	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	—	4 participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	—	8 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Analysis was not able to be done due to the small sample size.

To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 months

Population: Analysis was not able to be done due to the small sample size.

To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 months

Population: Analysis was not able to be done due to the small sample size.

To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 months

Population: Analysis was not able to be done due to the small sample size.

To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain

Outcome measures

Outcome data not reported

Adverse Events

Nexium Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo to Nexium, Alone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Viokase 16 Plus Nexium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Viokase 16 Plus Placebo to Nexium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nexium Alone n=3 participants at risk Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium	Placebo to Nexium, Alone n=3 participants at risk Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium	Viokase 16 Plus Nexium n=2 participants at risk Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium	Viokase 16 Plus Placebo to Nexium Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
Gastrointestinal disorders GI Pain	0.00% 0/3 • Adverse events were collected from 03/02/2009 until 08/15/2010	33.3% 1/3 • Number of events 1 • Adverse events were collected from 03/02/2009 until 08/15/2010	0.00% 0/2 • Adverse events were collected from 03/02/2009 until 08/15/2010	— 0/0 • Adverse events were collected from 03/02/2009 until 08/15/2010

Other adverse events

Measure	Nexium Alone n=3 participants at risk Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium	Placebo to Nexium, Alone n=3 participants at risk Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium	Viokase 16 Plus Nexium n=2 participants at risk Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium	Viokase 16 Plus Placebo to Nexium Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
Hepatobiliary disorders Elevated Liver Enzymes	33.3% 1/3 • Number of events 1 • Adverse events were collected from 03/02/2009 until 08/15/2010	0.00% 0/3 • Adverse events were collected from 03/02/2009 until 08/15/2010	0.00% 0/2 • Adverse events were collected from 03/02/2009 until 08/15/2010	— 0/0 • Adverse events were collected from 03/02/2009 until 08/15/2010

Additional Information

Phillip Toskes, M.D.

University of Florida

Phone: 352-273-9493

Email: phillip.toskes@medicine.ufl.edu

Results disclosure agreements

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