Trial · NCT00690820

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)

NCT00690820, Phase 3, Completed, Solvay Pharmaceuticals; results first posted 2010-03-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF). Trials, record NCT00690820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00690820

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
NCT number: NCT00690820
Status: Completed
Phases: Phase 3
Enrollment: 17 participants, actual
Lead sponsor: Solvay Pharmaceuticals
Conditions: Cystic Fibrosis, Pancreatic Exocrine Insufficiency
Interventions: Pancrelipase Delayed Release, Placebo Comparator
First posted: 2008-06-05
Last updated: 2010-06-02
Results first posted: 2010-03-10

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Coefficient of Fat Absorption (%)	5 days	This coefficient is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
Secondary	Coefficient of Nitrogen Absorption (%)	5 days	This coefficient is calculated from nitrogen intake and nitrogen excretion : 100\*\[nitrogen intake-nitrogen excretion\]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
Secondary	Total Fat Excretion (Grams)	5 days	Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
Secondary	Total Stool Weight (Grams)	5 days	Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
Secondary	Stool Frequency	5 days	Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.
Secondary	Percentage of Days With no Flatulence.	5 days	The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.
Secondary	Percentage of Days With Formed/Normal Stools.	5 days	The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.
Secondary	Percentage of Days With no Abdominal Pain.	5 days	The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Coefficient of Fat Absorption (%)	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Percentage	MEAN
SECONDARY	Coefficient of Nitrogen Absorption (%)	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Percentage	MEAN
SECONDARY	Total Fat Excretion (Grams)	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Grams	MEAN
SECONDARY	Total Stool Weight (Grams)	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Grams	MEAN
SECONDARY	Stool Frequency	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Number per day	MEAN
SECONDARY	Percentage of Days With no Flatulence.	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Percentage of days	MEAN
SECONDARY	Percentage of Days With Formed/Normal Stools.	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Percentage of days	MEAN
SECONDARY	Percentage of Days With no Abdominal Pain.	5 days	The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.	Percentage of days	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Coefficient of Fat Absorption (%)	Placebo	47.41	Standard Deviation 16.84	Percentage
Coefficient of Fat Absorption (%)	Pancrelipase	82.81	Standard Deviation 8.29	Percentage
Coefficient of Nitrogen Absorption (%)	Placebo	44.98	Standard Deviation 20.47	Percentage
Coefficient of Nitrogen Absorption (%)	Pancrelipase	80.33	Standard Deviation 7.92	Percentage
Total Fat Excretion (Grams)	Placebo	182.9	Standard Deviation 68.0	Grams
Total Fat Excretion (Grams)	Pancrelipase	58.1	Standard Deviation 27.5	Grams
Total Stool Weight (Grams)	Placebo	436.5	Standard Deviation 158.4	Grams
Total Stool Weight (Grams)	Pancrelipase	161.4	Standard Deviation 57.5	Grams
Stool Frequency	Placebo	3.46	Standard Deviation 1.06	Number per day
Stool Frequency	Pancrelipase	1.88	Standard Deviation 0.82	Number per day

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Placebo/Pancrelipase	8
Period 1	STARTED	Pancrelipase/Placebo	9
Period 1	COMPLETED	Placebo/Pancrelipase	8
Period 1	COMPLETED	Pancrelipase/Placebo	8
Period 1	NOT COMPLETED	Placebo/Pancrelipase	0
Period 1	NOT COMPLETED	Pancrelipase/Placebo	1
Period 2	STARTED	Placebo/Pancrelipase	8
Period 2	STARTED	Pancrelipase/Placebo	8
Period 2	COMPLETED	Placebo/Pancrelipase	8
Period 2	COMPLETED	Pancrelipase/Placebo	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Rectal Discharge	Gastrointestinal disorders	Placebo	1	16
other	Rectal Discharge	Gastrointestinal disorders	Pancrelipase	0	17
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	16
other	Diarrhoea	Gastrointestinal disorders	Pancrelipase	0	17
other	Faecal Volume Increased	Gastrointestinal disorders	Placebo	1	16
other	Faecal Volume Increased	Gastrointestinal disorders	Pancrelipase	0	17
other	Flatulence	Gastrointestinal disorders	Placebo	2	16
other	Flatulence	Gastrointestinal disorders	Pancrelipase	0	17
other	Abdominal Pain	Gastrointestinal disorders	Placebo	4	16
other	Abdominal Pain	Gastrointestinal disorders	Pancrelipase	1	17

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Pancrelipase
Total, other adverse events	Placebo	9	16
Total, other adverse events	Pancrelipase	5	17
Total, serious adverse events	Placebo	0	16
Total, serious adverse events	Pancrelipase	0	17

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20171415	RESULT	PubMed
21681115	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Pancrelipase vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00690820

GET https://conductscience.org/api/trials/v1/NCT00690820/events?page=2

API reference For AI assistants