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Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT01993875
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborators:
Sucampo Pharma Americas, LLC
Takeda
Sucampo AG
Information provided by (Responsible Party):
Mallinckrodt

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Idiopathic Constipation
Interventions Drug: Lubiprostone
Drug: Placebo
Enrollment 164
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description Participants received liquid formulation of Lubiprostone drug, 12 microgram (mcg) x 2 pumps administered orally twice daily (BID). Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Period Title: Overall Study
Started 82 82
Completed 75 76
Not Completed 7 6
Arm/Group Title Lubiprostone Placebo Total
Hide Arm/Group Description Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID. Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID. Total of all reporting groups
Overall Number of Baseline Participants 82 82 164
Hide Baseline Analysis Population Description
Modified intent-to-treat (mITT) Population included all participants who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 164 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
78
  95.1%
75
  91.5%
153
  93.3%
>=65 years
4
   4.9%
7
   8.5%
11
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 82 participants 164 participants
47.2  (12.51) 45.0  (12.82) 46.1  (12.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 164 participants
Female
55
  67.1%
58
  70.7%
113
  68.9%
Male
27
  32.9%
24
  29.3%
51
  31.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 164 participants
Hispanic or Latino
29
  35.4%
29
  35.4%
58
  35.4%
Not Hispanic or Latino
53
  64.6%
53
  64.6%
106
  64.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 164 participants
American Indian or Alaska Native
1
   1.2%
1
   1.2%
2
   1.2%
Asian
0
   0.0%
2
   2.4%
2
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
42
  51.2%
38
  46.3%
80
  48.8%
White
38
  46.3%
40
  48.8%
78
  47.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.2%
1
   1.2%
2
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 82 participants 164 participants
82 82 164
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 82 participants 82 participants 164 participants
29.5  (5.03) 30.9  (6.50) 30.2  (5.84)
Previous AMITIZA use at randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 164 participants
No
80
  97.6%
81
  98.8%
161
  98.2%
Yes
2
   2.4%
1
   1.2%
3
   1.8%
1.Primary Outcome
Title Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
Hide Description SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Time Frame within 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention to Treat (mITT), defined as all participants who received at least 1 dose of study medication.
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description:
Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: number of SBMs
4.6  (3.33) 4.0  (3.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lubiprostone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1290
Comments Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Consistency of SBMs at Week 1
Hide Description Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
Time Frame at Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description:
Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.2  (3.12) 2.4  (3.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lubiprostone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1290
Comments Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Overall Stool Consistency at Week 1
Hide Description Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
Time Frame at Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description:
Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.3  (1.38) 3.0  (1.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lubiprostone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2177
Comments Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline in Stool Consistency at Week 1
Hide Description Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).
Time Frame Baseline and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description:
Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.8  (0.91) 1.9  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lubiprostone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2177
Comments Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Overall Straining at Week 1
Hide Description Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description:
Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.8  (0.91) 1.9  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lubiprostone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0664
Comments Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in Straining at Week 1
Hide Description Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description:
Participants received liquid formulation of Lubiprostone drug, 12 microgram (mcg) x 2 pumps administered orally twice daily (BID).
Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Number of Participants Analyzed 82 82
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.1  (0.94) -0.8  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lubiprostone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0664
Comments Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.
Method ANCOVA
Comments [Not Specified]
Time Frame Up to 7 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lubiprostone Placebo
Hide Arm/Group Description Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID. Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
All-Cause Mortality
Lubiprostone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/82 (0.00%) 
Hide Serious Adverse Events
Lubiprostone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/82 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Lubiprostone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/82 (25.61%)   15/82 (18.29%) 
Gastrointestinal disorders     
Nausea  1  9/82 (10.98%)  1/82 (1.22%) 
Flatulence  1  7/82 (8.54%)  6/82 (7.32%) 
Abdominal distension  1  1/82 (1.22%)  3/82 (3.66%) 
Abdominal pain  1  1/82 (1.22%)  3/82 (3.66%) 
Infections and infestations     
Upper respiratory tract infection  1  2/82 (2.44%)  0/82 (0.00%) 
Nervous system disorders     
Headache  1  6/82 (7.32%)  9/82 (10.98%) 
Presyncope  1  5/82 (6.10%)  0/82 (0.00%) 
Dizziness  1  2/82 (2.44%)  0/82 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Throat irritation  1  2/82 (2.44%)  0/82 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Medical Information Call Center
Organization: Mallinckrodt
Phone: 800-556-3314
EMail: clinicaltrials@mnk.com
Layout table for additonal information
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01993875    
Other Study ID Numbers: SCMP-0211-301
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: October 14, 2019
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019