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Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

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ClinicalTrials.gov Identifier: NCT00452335
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Constipation
Intervention Drug: Lubiprostone
Enrollment 127
Recruitment Details  
Pre-assignment Details 127 participants were randomized to study treatment, however only 124 participants received study drug
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
Period Title: Overall Study
Started 27 65 32
Completed 25 61 23
Not Completed 2 4 9
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID Total
Hide Arm/Group Description Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight Total of all reporting groups
Overall Number of Baseline Participants 27 65 32 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 65 participants 32 participants 124 participants
<=18 years
27
 100.0%
65
 100.0%
32
 100.0%
124
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 65 participants 32 participants 124 participants
5.5  (1.67) 10.3  (2.78) 13.9  (3.00) 10.2  (3.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 65 participants 32 participants 124 participants
Female
12
  44.4%
24
  36.9%
23
  71.9%
59
  47.6%
Male
15
  55.6%
41
  63.1%
9
  28.1%
65
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 65 participants 32 participants 124 participants
27 65 32 124
1.Primary Outcome
Title Frequency of Spontaneous Bowel Movements
Hide Description Gathered as part of the daily electronic diary questions.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: spontaneous bowel movements per week
2.47  (2.68) 3.02  (2.17) 3.84  (2.51)
2.Secondary Outcome
Title Frequency of Spontaneous Bowel Movements
Hide Description Gathered as part of the daily electronic diary questions.
Time Frame Weeks 2, 3, and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: spontaneous bowel movements per week
Week 2 2.79  (2.278) 2.59  (2.316) 3.51  (1.897)
Week 3 2.64  (2.210) 2.60  (2.006) 3.58  (2.422)
Week 4 2.85  (2.130) 2.68  (2.258) 2.99  (1.827)
3.Secondary Outcome
Title Frequency of Fecal Incontinence
Hide Description As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: episodes of fecal incontinence per day
Week 1 0.53  (1.141) 0.22  (0.489) 0.03  (0.089)
Week 2 0.37  (0.768) 0.21  (0.446) 0.05  (0.148)
Week 3 0.40  (0.989) 0.16  (0.336) 0.01  (0.060)
Week 4 0.48  (1.168) 0.17  (0.457) 0.02  (0.074)
4.Secondary Outcome
Title Straining Associated With SBMs
Hide Description Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 Mch BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 1.70  (1.074) 1.34  (1.001) 1.44  (0.890)
Week 2 1.02  (1.010) 1.22  (0.868) 1.30  (1.003)
Week 3 1.11  (0.857) 1.11  (0.809) 1.16  (1.130)
Week 4 1.03  (0.887) 1.31  (1.096) 0.97  (1.089)
5.Secondary Outcome
Title Stool Consistency of SBMs
Hide Description Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 2.87  (1.197) 3.20  (1.168) 3.14  (1.249)
Week 2 3.09  (1.078) 2.90  (1.198) 3.22  (1.394)
Week 3 2.93  (0.796) 3.31  (1.121) 3.59  (1.168)
Week 4 3.20  (0.904) 2.96  (1.160) 4.01  (1.631)
6.Secondary Outcome
Title Abdominal Bloating
Hide Description Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 1.16  (0.800) 1.39  (1.150) 1.79  (0.876)
Week 2 1.08  (0.929) 1.12  (1.027) 1.16  (0.987)
Week 3 0.82  (1.006) 1.00  (0.937) 1.08  (1.018)
Week 4 0.96  (1.065) 1.04  (0.865) 1.05  (0.950)
7.Secondary Outcome
Title Abdominal Discomfort
Hide Description Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg BID 12 mcg QD 24 mcg BID
Hide Arm/Group Description:
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 0.84  (0.800) 1.16  (1.134) 1.43  (1.289)
Week 2 1.08  (0.929) 0.93  (0.918) 1.20  (1.080)
Week 3 0.82  (0.795) 0.90  (0.892) 1.17  (1.204)
Week 4 0.87  (0.869) 1.05  (0.915) 1.14  (1.125)
8.Secondary Outcome
Title Pain Associated With SBMs
Hide Description Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 1.56  (1.051) 1.13  (0.970) 1.14  (0.873)
Week 2 0.72  (1.009) 1.06  (0.758) 1.10  (1.073)
Week 3 0.88  (0.929) 0.91  (0.915) 1.01  (1.089)
Week 4 0.82  (0.978) 1.07  (1.047) 1.07  (1.298)
9.Secondary Outcome
Title Constipation Severity
Hide Description Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 1.92  (1.038) 1.69  (0.951) 1.79  (0.917)
Week 2 1.46  (0.977) 1.43  (0.945) 1.40  (0.816)
Week 3 1.59  (0.908) 1.36  (1.055) 1.38  (0.875)
Week 4 1.43  (1.121) 1.28  (1.031) 1.59  (1.054)
10.Secondary Outcome
Title Treatment Effectiveness
Hide Description Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.
Time Frame Weekly, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description:
Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Overall Number of Participants Analyzed 27 65 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 1.2  (1.30) 1.6  (1.27) 1.7  (0.86)
Week 2 1.6  (1.28) 1.7  (1.24) 2.0  (1.17)
Week 3 1.9  (1.51) 1.8  (1.31) 1.8  (1.24)
Week 4 2.0  (1.43) 1.8  (1.22) 1.9  (1.10)
Time Frame Treatment-emergent AEs: up to 4 weeks plus 7 days (from time of first dose to 7 days post-treatment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 12 mcg QD 12 mcg BID 24 mcg BID
Hide Arm/Group Description Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
All-Cause Mortality
12 mcg QD 12 mcg BID 24 mcg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
12 mcg QD 12 mcg BID 24 mcg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   1/65 (1.54%)   0/32 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  0/27 (0.00%)  1/65 (1.54%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
12 mcg QD 12 mcg BID 24 mcg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/27 (18.52%)   23/65 (35.38%)   14/32 (43.75%) 
Gastrointestinal disorders       
Abdominal pain  2/27 (7.41%)  4/65 (6.15%)  3/32 (9.38%) 
Diarrhoea  3/27 (11.11%)  4/65 (6.15%)  3/32 (9.38%) 
Nausea  1/27 (3.70%)  12/65 (18.46%)  10/32 (31.25%) 
Vomiting  4/27 (14.81%)  6/65 (9.23%)  5/32 (15.63%) 
Nervous system disorders       
Headache  0/27 (0.00%)  4/65 (6.15%)  3/32 (9.38%) 
1
Term from vocabulary, MedDRA 10.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP, Clinical Development
Organization: Sucampo Pharma Americas, Inc.
Phone: 301-961-3400
EMail: info@sucampo.com
Layout table for additonal information
Responsible Party: Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00452335     History of Changes
Other Study ID Numbers: 0211SC-0641
First Submitted: March 26, 2007
First Posted: March 27, 2007
Results First Submitted: February 16, 2016
Results First Posted: August 22, 2016
Last Update Posted: August 22, 2016