Trial Outcomes & Findings for A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy (NCT NCT00414908)

NCT ID: NCT00414908

Last Updated: 2011-08-10

Results Overview

The CFA is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 52 participants
• Primary outcome timeframe: End of double-blind period (5-7 days)
• Results posted on: 2011-08-10

Participant Flow

Subjects were recruited in centers in Bulgaria, Poland, Russia, Serbia, Ukraine and US between April 2007 and August 2008. This report presents the double-blind (DB) period of the study as well as the Open Label (OL) results.

There was a run-in with a 5-day of single-blind placebo treatment. One hundred and eighty subjects were consented and 179 entered the run-in. A total of 54 subjects were randomly allocated to treatment. Only two subjects did not complete the DB period of the treatment because of protocol violation. Fifty one patients entered the OL period.

Participant milestones

Measure	Pancrelipase (DB) Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) Placebo group given during the Double-Blind period
Overall Study STARTED	25	29
Overall Study COMPLETED	24	28
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Pancrelipase (DB) Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) Placebo group given during the Double-Blind period
Overall Study Protocol Violation	1	1

Baseline Characteristics

A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

Baseline characteristics by cohort

Measure	Pancrelipase (DB) n=24 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=28 Participants Placebo group given during the Double-Blind period	Total n=52 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	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	51.7 years STANDARD_DEVIATION 9.7 • n=5 Participants	50.4 years STANDARD_DEVIATION 7.8 • n=7 Participants	51.0 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Serbia	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Poland	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Ukraine	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Russian Federation	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Bulgaria	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: End of double-blind period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.

Change is calculated as (DB CFA-Baseline CFA).

Outcome measures

Measure	Pancrelipase (DB) n=22 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=27 Participants Placebo group given during the Double-Blind period
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.	31.93 Percentage Standard Deviation 18.57	8.72 Percentage Standard Deviation 12.44

SECONDARY outcome

Timeframe: End of double-blind period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).

Outcome measures

Measure	Pancrelipase (DB) n=22 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=27 Participants Placebo group given during the Double-Blind period
Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.	35.23 Percentage Standard Deviation 29.05	8.85 Percentage Standard Deviation 28.04

SECONDARY outcome

Timeframe: End of double-blind period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).

Outcome measures

Measure	Pancrelipase (DB) n=22 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=27 Participants Placebo group given during the Double-Blind period
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.	-147.08 Grammes Standard Error 12.71	-34.62 Grammes Standard Error 11.47

SECONDARY outcome

Timeframe: End of double-period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).

Outcome measures

Measure	Pancrelipase (DB) n=22 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=27 Participants Placebo group given during the Double-Blind period
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.	-17.55 Grammes Standard Error 2.06	-5.87 Grammes Standard Error 1.85

SECONDARY outcome

Timeframe: End of double-period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).

Outcome measures

Measure	Pancrelipase (DB) n=23 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=28 Participants Placebo group given during the Double-Blind period
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period	-0.55 Number Standard Error 0.19	0.20 Number Standard Error 0.17

SECONDARY outcome

Timeframe: End of double-period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).

Outcome measures

Measure	Pancrelipase (DB) n=23 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=28 Participants Placebo group given during the Double-Blind period
Abdominal Pain at the End of the Double-blind Period. 0 (None)	12 Participants	8 Participants
Abdominal Pain at the End of the Double-blind Period. 1 (Mild)	7 Participants	12 Participants
Abdominal Pain at the End of the Double-blind Period. 2 (Moderate)	4 Participants	7 Participants
Abdominal Pain at the End of the Double-blind Period. 3 (Severe)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: End of double-period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).

Outcome measures

Measure	Pancrelipase (DB) n=23 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=28 Participants Placebo group given during the Double-Blind period
Stool Consistency at the End of the Double-blind Period 3 (Watery)	0 Participants	3 Participants
Stool Consistency at the End of the Double-blind Period 0 (Hard)	0 Participants	0 Participants
Stool Consistency at the End of the Double-blind Period 1 (Formed/Normal)	11 Participants	5 Participants
Stool Consistency at the End of the Double-blind Period 2 (Soft)	12 Participants	20 Participants

SECONDARY outcome

Timeframe: End of double-period (5-7 days)

Population: The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.

4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).

Outcome measures

Measure	Pancrelipase (DB) n=23 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) n=28 Participants Placebo group given during the Double-Blind period
Flatulence at the End of Double-blind Period 0 (None)	6 Participants	0 Participants
Flatulence at the End of Double-blind Period 1 (Mild)	13 Participants	15 Participants
Flatulence at the End of Double-blind Period 2 (Moderate)	4 Participants	12 Participants
Flatulence at the End of Double-blind Period 3 (Severe)	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 27 weeks

Population: This analysis is done on the Open-Label period of 6 months.

Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency).

Outcome measures

Measure	Pancrelipase (DB) n=47 Participants Pancrelipase delayed release capsules given during the Double-Blind period	Placebo (DB) Placebo group given during the Double-Blind period
Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL)	-0.98 Number Standard Deviation 1.26	—

Adverse Events

Pancrelipase (DB)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo (DB)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Pancrelipase (OL)

Serious events: 7 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pancrelipase (DB) n=24 participants at risk Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period	Placebo (DB) n=28 participants at risk Placebo group meaning the treatment received during the 7-days double-blind period	Pancrelipase (OL) n=51 participants at risk Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
Gastrointestinal disorders Acute and Chronic Pancreatitis	0.00% 0/24	0.00% 0/28	2.0% 1/51
Injury, poisoning and procedural complications Lower Limb Fractures and dislocations	0.00% 0/24	0.00% 0/28	2.0% 1/51
Injury, poisoning and procedural complications Thermal Burns	0.00% 0/24	0.00% 0/28	2.0% 1/51
Metabolism and nutrition disorders Diabetes Mellitus (Incl Subtypes)	0.00% 0/24	0.00% 0/28	3.9% 2/51
Metabolism and nutrition disorders Diabetic Complication Dermal	0.00% 0/24	0.00% 0/28	2.0% 1/51
Respiratory, thoracic and mediastinal disorders Parenchymal Lung Disorders NEC	0.00% 0/24	0.00% 0/28	2.0% 1/51

Other adverse events

Measure	Pancrelipase (DB) n=24 participants at risk Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period	Placebo (DB) n=28 participants at risk Placebo group meaning the treatment received during the 7-days double-blind period	Pancrelipase (OL) n=51 participants at risk Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
Metabolism and nutrition disorders Hyperglycaemic conditions NEC	4.2% 1/24	7.1% 2/28	0.00% 0/51
Infections and infestations Upper respiratory Tract infections	0.00% 0/24	0.00% 0/28	7.8% 4/51

Additional Information

Sven Voet - Global Communication

Abbott Products

Phone: +41 61 487 08 56

Email: sven.voet@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment.
• Publication restrictions are in place

Restriction type: OTHER