AZ: Viokase 16, Viokase16 Plus Nexium and Nexium Alone

• Sponsor: University of Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01142128
• Collaborator: AstraZeneca (Industry)
• Enrollment: 12
• Location: 1
• Arms: 4
• Duration (Months): 36.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Drug: Nexium (esomeprazole magnesium); Drug: Placebo to Nexium; Drug: Viokase 16 (pancrelipase) + Nexium; Drug: Viokase 16 + placebo to Nexium	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single Site, Double Blind, Fixed Dose, Cross Over Study of Viokase 16, Viokase16 Plus Nexium and Nexium Alone in the Reduction of Abdominal Pain in Patients With Chronic Pancreatitis
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Nexium (esomeprazole magnesium); one 40 mg capsule per day for one month; Other Names: Nexium
Placebo Comparator: 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	Drug: Placebo to Nexium; one capsule per day for one month
Active Comparator: Viokase 16 (pancrelipase) + Nexium Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month.	Drug: Viokase 16 (pancrelipase) + Nexium; Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month
Placebo Comparator: Viokase 16 + 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	Drug: Viokase 16 + placebo to Nexium; Viokase 16 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month

Outcome Measures

Primary Outcome Measures

1. Reduction of Abdominal Pain for Participants Taking Nexium Alone. [4 months]

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

2. Reduction of Abdominal Pain for Participants Taking Placebo to Nexium [4 months]

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

3. Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium [4 months]

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

4. Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo. [4 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.

2. History of abdominal pain associated with chronic pancreatitis

3. Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase > 100ug/g stool, or serum trypsinogen > 20ng/ml

Exclusion Criteria:

1. Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.

2. Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.

3. Female subjects who are pregnant or lactating

4. Subject use of enzyme therapy other than that called for in this study

5. Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.

6. Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida
• AstraZeneca

Investigators

• Principal Investigator: Phillip P Toskes, M.D., University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01142128
• Other Study ID Numbers: D.9612.L00058
• First Posted: Jun 11, 2010
• Last Update Posted: Feb 21, 2013
• Last Verified: Feb 1, 2013

• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic; Esomeprazole; Pancrelipase; Pancreatin

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	All Participants
Arm/Group Description	Participants received one of four interventions in a randomized crossover design: 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 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 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 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
Period Title: Overall Study
STARTED	8
Nexium Alone	3
Placebo to Nexium, Alone	3
Viokase 16 Plus Nexium	2
Viokase 16 Plus Placebo to Nexium	0
COMPLETED	4
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Nexium Alone	Placebo to Nexium, Alone	Viokase 16 Plus Nexium	Viokase 16 Plus Placebo to Nexium	Total
Arm/Group Description	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 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 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 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 of all reporting groups
Overall Participants	3	3	2	0	8
Age (participants) [Number]
<=18 years	0 0%	0 0%	0 0%	0 NaN
Between 18 and 65 years	3 100%	2 66.7%	2 100%	7 Infinity
>=65 years	0 0%	1 33.3%	0 0%	1 Infinity
Gender (participants) [Number]
Female	1 33.3%	2 66.7%	1 50%	4 Infinity
Male	2 66.7%	1 33.3%	1 50%	4 Infinity
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	2 100%	8 Infinity

Outcome Measures

1. Primary Outcome

Title	Reduction of Abdominal Pain for Participants Taking Nexium Alone.
Description	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Nexium Alone
Arm/Group Description	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
Measure Participants	0

2. Primary Outcome

Title	Reduction of Abdominal Pain for Participants Taking Placebo to Nexium
Description	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo to Nexium, Alone
Arm/Group Description	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
Measure Participants	0

3. Primary Outcome

Title	Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium
Description	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Viokase 16 Plus Nexium
Arm/Group Description	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
Measure Participants	0

4. Primary Outcome

Title	Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.
Description	To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Viokase 16 Plus Placebo to Nexium
Arm/Group Description	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
Measure Participants	0

Adverse Events

Time Frame	Adverse events were collected from 03/02/2009 until 08/15/2010
Arm/Group Title	Nexium Alone		Placebo to Nexium, Alone		Viokase 16 Plus Nexium		Viokase 16 Plus Placebo to Nexium
Arm/Group Description	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 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 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 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
All Cause Mortality
	Nexium Alone		Placebo to Nexium, Alone		Viokase 16 Plus Nexium		Viokase 16 Plus Placebo to Nexium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Nexium Alone		Placebo to Nexium, Alone		Viokase 16 Plus Nexium		Viokase 16 Plus Placebo to Nexium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/3 (33.3%)		0/2 (0%)		0/0 (NaN)
Gastrointestinal disorders
GI Pain	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	Nexium Alone		Placebo to Nexium, Alone		Viokase 16 Plus Nexium		Viokase 16 Plus Placebo to Nexium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		0/3 (0%)		0/2 (0%)		0/0 (NaN)
Hepatobiliary disorders
Elevated Liver Enzymes	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.