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A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00788593
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Interventions Drug: Placebo
Drug: EUR-1008 (APT-1008) High Dose
Drug: EUR-1008 (APT-1008) Low Dose
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Baseline EUR-1008 (APT-1008) High Dose, Then Low Dose EUR-1008 (APT-1008) Low Dose, Then High Dose
Hide Arm/Group Description Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008). EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment. EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
Period Title: Placebo Run-in Phase
Started 82 0 0
Completed 76 0 0
Not Completed 6 0 0
Reason Not Completed
Adverse Event             2             0             0
Withdrawal by Subject             2             0             0
Protocol Violation             2             0             0
Period Title: First Intervention Period
Started 0 39 37
Completed 0 38 37
Not Completed 0 1 0
Reason Not Completed
Adverse Event             0             1             0
Period Title: Second Intervention Period
Started 0 38 37
Completed 0 37 36
Not Completed 0 1 1
Reason Not Completed
Lost to Follow-up             0             1             0
Other             0             0             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
Overall Number of Baseline Participants 82
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 dose of the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants
51.91  (12.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
Female
29
  35.4%
Male
53
  64.6%
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 82 participants
68.75  (14.12)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 82 participants
23.36  (4.44)
[1]
Measure Description: BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).
1.Primary Outcome
Title Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008
Hide Description Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.
Time Frame 3 to 5 days of hospital treatment in first and second intervention periods
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of the study medication. Here "N" (number of participants analyzed) signifies those participants for whom the CFA values were available.
Arm/Group Title EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Hide Arm/Group Description:
EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: percent CFA
88.87  (12.44) 89.86  (8.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EUR-1008 (APT-1008) Low Dose, EUR-1008 (APT-1008) High Dose
Comments Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value 1.023
Confidence Interval (2-Sided) 95%
-0.656 to 2.701
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment
Hide Description Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.
Time Frame Baseline, 3 to 5 days of hospital treatment in first and second intervention periods
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of the study medication. Here "N" (number of participants analyzed) signifies those participants for whom the CFA values were available.
Arm/Group Title Placebo Baseline EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Hide Arm/Group Description:
Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 82 72 72
Mean (Standard Deviation)
Unit of Measure: percent CFA
Baseline 81.68  (22.13) NA [1]   (NA) NA [2]   (NA)
Change During Hospital Period NA [3]   (NA) 7.19  (14.49) 8.18  (17.35)
[1]
Data was not reported as EUR-1008 low dose was not given at baseline.
[2]
Data was not reported as EUR-1008 high dose was not given at baseline.
[3]
Data was not reported as placebo was not given during hospital treatment period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Baseline, EUR-1008 (APT-1008) Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Baseline, EUR-1008 (APT-1008) High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment
Hide Description Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.
Time Frame Baseline, 3 to 5 days of hospital treatment in first and second intervention periods
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of the study drug. Here "N" (number of participants analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Baseline EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Hide Arm/Group Description:
Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 82 74 75
Mean (Standard Deviation)
Unit of Measure: percent CNA
Baseline 78.05  (18.64) NA [1]   (NA) NA [2]   (NA)
Change During Hospital Period NA [3]   (NA) 5.33  (10.38) 7.62  (15.55)
[1]
Data was not reported as EUR-1008 low dose was not given at baseline.
[2]
Data was not reported as EUR-1008 high dose was not given at baseline.
[3]
Data was not reported as placebo was not given during hospital treatment period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Baseline, EUR-1008 (APT-1008) Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Baseline, EUR-1008 (APT-1008) High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change From Placebo Baseline in Weight at End of Each Treatment Period
Hide Description Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.
Time Frame Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of the study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Hide Arm/Group Description:
EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 74 75
Mean (Standard Deviation)
Unit of Measure: kilogram (kg)
0.38  (1.18) 0.50  (1.31)
5.Secondary Outcome
Title Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment
Hide Description BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.
Time Frame Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of the study medication. Here "N" (number of participants analyzed) represents number of participants who were evaluable for this outcome measure.
Arm/Group Title EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Hide Arm/Group Description:
EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 74 75
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.13  (0.39) 0.16  (0.42)
Time Frame Baseline up to final follow-up visit (14 days after end of study)
Adverse Event Reporting Description Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
 
Arm/Group Title Placebo Baseline EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Hide Arm/Group Description Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008). EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
All-Cause Mortality
Placebo Baseline EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Baseline EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/82 (2.44%)   2/74 (2.70%)   2/75 (2.67%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Obstruction gastric * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Pancreatic pseudocyst * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
General disorders       
Pyrexia * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Hepatobiliary disorders       
Bile duct obstruction * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications       
Renal injury * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Wrist fracture * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Nervous system disorders       
Cognitive disorder * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Renal and urinary disorders       
Nephrolithiasis * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Baseline EUR-1008 (APT-1008) Low Dose EUR-1008 (APT-1008) High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/82 (41.46%)   28/74 (37.84%)   31/75 (41.33%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Cardiac disorders       
Supraventricular tachycardia * 1  0/82 (0.00%)  1/74 (1.35%)  1/75 (1.33%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/82 (0.00%)  2/74 (2.70%)  0/75 (0.00%) 
Abdominal pain * 1  12/82 (14.63%)  7/74 (9.46%)  13/75 (17.33%) 
Abdominal pain upper * 1  1/82 (1.22%)  1/74 (1.35%)  1/75 (1.33%) 
Constipation * 1  1/82 (1.22%)  2/74 (2.70%)  5/75 (6.67%) 
Diarrhoea * 1  5/82 (6.10%)  3/74 (4.05%)  1/75 (1.33%) 
Dyspepsia * 1  2/82 (2.44%)  1/74 (1.35%)  1/75 (1.33%) 
Flatulence * 1  18/82 (21.95%)  7/74 (9.46%)  10/75 (13.33%) 
Frequent bowel movements * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Gastrooesophageal reflux disease * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Haematochezia * 1  1/82 (1.22%)  1/74 (1.35%)  0/75 (0.00%) 
Nausea * 1  2/82 (2.44%)  3/74 (4.05%)  1/75 (1.33%) 
Steatorrhoea * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Stomach discomfort * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Vomiting * 1  3/82 (3.66%)  1/74 (1.35%)  2/75 (2.67%) 
General disorders       
Asthenia * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Chest pain * 1  1/82 (1.22%)  0/74 (0.00%)  1/75 (1.33%) 
Malaise * 1  0/82 (0.00%)  2/74 (2.70%)  0/75 (0.00%) 
Pyrexia * 1  0/82 (0.00%)  1/74 (1.35%)  2/75 (2.67%) 
Infections and infestations       
Nasopharyngitis * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Urinary tract infection * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Blood alkaline phosphatase increased * 1  2/82 (2.44%)  0/74 (0.00%)  0/75 (0.00%) 
Blood cholesterol increased * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Blood glucose abnormal * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Blood triglycerides increased * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Blood uric acid decreased * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Hepatic enzyme increased * 1  2/82 (2.44%)  0/74 (0.00%)  0/75 (0.00%) 
Liver function test abnormal * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Low density lipoprotein increased * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Protein induced by vitamin K absence or antagonist II increased * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Metabolism and nutrition disorders       
Diabetes mellitus * 1  1/82 (1.22%)  0/74 (0.00%)  1/75 (1.33%) 
Hyperglycaemia * 1  1/82 (1.22%)  0/74 (0.00%)  2/75 (2.67%) 
Hyperkalaemia * 1  1/82 (1.22%)  0/74 (0.00%)  1/75 (1.33%) 
Hyperlipidaemia * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Hypoglycaemia * 1  1/82 (1.22%)  0/74 (0.00%)  0/75 (0.00%) 
Hypokalaemia * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Vitamin A deficiency * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Vitamin E deficiency * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Musculoskeletal stiffness * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Pain in extremity * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Nervous system disorders       
Dizziness * 1  2/82 (2.44%)  0/74 (0.00%)  0/75 (0.00%) 
Headache * 1  3/82 (3.66%)  4/74 (5.41%)  2/75 (2.67%) 
Hypoaesthesia * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Psychiatric disorders       
Insomnia * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Reproductive system and breast disorders       
Breast tenderness * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Productive cough * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Sinus congestion * 1  0/82 (0.00%)  0/74 (0.00%)  1/75 (1.33%) 
Surgical and medical procedures       
Sinus operation * 1  0/82 (0.00%)  1/74 (1.35%)  0/75 (0.00%) 
Vascular disorders       
Hypertension * 1  0/82 (0.00%)  1/74 (1.35%)  1/75 (1.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Restrictions vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor’s confidential information be removed from any publication and can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Winkler, MD, VP, Clinical Development and Operations
Organization: Aptalis Pharma US, Inc.
Phone: 1-800-472-2634
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00788593     History of Changes
Other Study ID Numbers: PR-002
First Submitted: November 10, 2008
First Posted: November 11, 2008
Results First Submitted: January 27, 2014
Results First Posted: March 12, 2014
Last Update Posted: March 12, 2014