Trial · NCT00297167
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
NCT00297167, Phase 3, Completed, Forest Laboratories; results first posted 2014-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency. Trials, record NCT00297167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00297167
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
- NCT number
- NCT00297167
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Interventions
- EUR-1008 (APT-1008), Placebo, Placebo, EUR-1008 (APT-1008)
- First posted
- 2006-02-28
- Last updated
- 2017-03-16
- Results first posted
- 2014-04-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Coefficient of Fat Absorption (CFA%) | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods. |
| Secondary | Percent Coefficient of Nitrogen Absorption (CNA%) | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Percent CNA was calculated as (\[nitrogen intake-nitrogen excretion\]/nitrogen intake)\*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods. |
| Secondary | Lipid Levels | End of treatment (Day 6 during first and second double-blind intervention periods) | Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated. |
| Secondary | Vitamin A Levels | End of treatment (Day 6 during first and second double-blind intervention periods) | Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated. |
| Secondary | Vitamin E Levels | End of treatment (Day 6 during first and second double-blind intervention periods) | Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated. |
| Secondary | Mean Daily Number of Stools | Day 3 up to Day 6 during first and second double-blind intervention periods | Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized. |
| Secondary | Percentage of Stool Categorized as Per Consistency | Day 3 up to Day 6 during first and second double-blind intervention periods | Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. |
| Secondary | Mean Number of Abdominal Symptoms | Day 3 up to Day 6 during first and second double-blind intervention periods | Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants. |
| Other | Percentage of Visible Oil or Grease in Stool | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day. |
| Other | Percentage of Stools With Blood | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Coefficient of Fat Absorption (CFA%) | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | percent CFA | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Coefficient of Nitrogen Absorption (CNA%) | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | percent CNA | LEAST_SQUARES_MEAN |
| SECONDARY | Lipid Levels | End of treatment (Day 6 during first and second double-blind intervention periods) | Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specific time point in each treatment arm. | milligram/deciliter (mg/dL) | MEAN |
| SECONDARY | Vitamin A Levels | End of treatment (Day 6 during first and second double-blind intervention periods) | Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | microgram per liter (mcg/L) | MEAN |
| SECONDARY | Vitamin E Levels | End of treatment (Day 6 during first and second double-blind intervention periods) | Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | mg/L | MEAN |
| SECONDARY | Mean Daily Number of Stools | Day 3 up to Day 6 during first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. | stools per day | MEAN |
| SECONDARY | Percentage of Stool Categorized as Per Consistency | Day 3 up to Day 6 during first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. | percentage of stools | MEAN |
| SECONDARY | Mean Number of Abdominal Symptoms | Day 3 up to Day 6 during first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. | symptoms per day | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Visible Oil or Grease in Stool | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. | percentage of visible oil or grease/day | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Stools With Blood | Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods | Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. | percentage of stools with blood per day | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Coefficient of Fat Absorption (CFA%) | EUR-1008 (APT-1008) | 88.28 | Standard Error 2.599 | percent CFA | |
| Percent Coefficient of Fat Absorption (CFA%) | Placebo | 62.76 | Standard Error 2.639 | percent CFA | |
| Percent Coefficient of Nitrogen Absorption (CNA%) | EUR-1008 (APT-1008) | 87.17 | Standard Error 2.179 | percent CNA | |
| Percent Coefficient of Nitrogen Absorption (CNA%) | Placebo | 65.67 | Standard Error 2.213 | percent CNA | |
| Lipid Levels | EUR-1008 (APT-1008) | TC: End of Treatment (n=33, 30) | 128.8 | Standard Deviation 28.98 | milligram/deciliter (mg/dL) |
| Lipid Levels | Placebo | TC: End of Treatment (n=33, 30) | 109.1 | Standard Deviation 29.76 | milligram/deciliter (mg/dL) |
| Lipid Levels | EUR-1008 (APT-1008) | HDL-C: End of Treatment (n=33, 30) | 45.5 | Standard Deviation 10.85 | milligram/deciliter (mg/dL) |
| Lipid Levels | Placebo | HDL-C: End of Treatment (n=33, 30) | 37.2 | Standard Deviation 9.23 | milligram/deciliter (mg/dL) |
| Vitamin A Levels | EUR-1008 (APT-1008) | 422.3 | Standard Deviation 111.67 | microgram per liter (mcg/L) | |
| Vitamin A Levels | Placebo | 363.2 | Standard Deviation 100.33 | microgram per liter (mcg/L) |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Double-blind Intervention Period | STARTED | Placebo First, Then EUR-1008 (APT-1008) | 17 | |
| First Double-blind Intervention Period | STARTED | EUR-1008 (APT-1008) First, Then Placebo | 16 | |
| First Double-blind Intervention Period | STARTED | EUR-1008 (APT-1008) (Open-label) | 0 | |
| First Double-blind Intervention Period | COMPLETED | Placebo First, Then EUR-1008 (APT-1008) | 17 | |
| First Double-blind Intervention Period | COMPLETED | EUR-1008 (APT-1008) First, Then Placebo | 16 | |
| First Double-blind Intervention Period | COMPLETED | EUR-1008 (APT-1008) (Open-label) | 0 | |
| First Double-blind Intervention Period | NOT COMPLETED | Placebo First, Then EUR-1008 (APT-1008) | 0 | |
| First Double-blind Intervention Period | NOT COMPLETED | EUR-1008 (APT-1008) First, Then Placebo | 0 | |
| First Double-blind Intervention Period | NOT COMPLETED | EUR-1008 (APT-1008) (Open-label) | 0 | |
| Open-label Dose Normalization Period 1 | STARTED | Placebo First, Then EUR-1008 (APT-1008) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events72
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | EUR-1008 (APT-1008) | 1 | 34 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 32 | |
| other | Abdominal distension | Gastrointestinal disorders | EUR-1008 (APT-1008) | 2 | 34 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 3 | 32 | |
| other | Abdominal pain | Gastrointestinal disorders | EUR-1008 (APT-1008) | 4 | 34 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 6 | 32 | |
| other | Abdominal pain upper | Gastrointestinal disorders | EUR-1008 (APT-1008) | 2 | 34 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 32 | |
| other | Abnormal faeces | Gastrointestinal disorders | EUR-1008 (APT-1008) | 1 | 34 | |
| other | Abnormal faeces | Gastrointestinal disorders | Placebo | 3 | 32 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EUR-1008 (APT-1008) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | EUR-1008 (APT-1008) | 19 | 34 |
| Total, other adverse events | Placebo | 16 | 32 |
| Total, serious adverse events | EUR-1008 (APT-1008) | 2 | 34 |
| Total, serious adverse events | Placebo | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19683970 | DERIVED |
Source 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 |
|---|
| EUR-1008 (APT-1008) 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.
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.
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