Lubiprostone for Chronic Idiopathic Constipation Treatment
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|ClinicalTrials.gov Identifier: NCT02729909|
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Lubiprostone Drug: Placebo||Phase 3|
The drug being tested in this study is called lubiprostone. Lubiprostone is being tested to treat people who have chronic idiopathic constipation. This study will look at the frequency of spontaneous bowel movements (SBMs) in people who take lubiprostone compared to placebo.
The study will enroll approximately 211 participants. Participants will be randomly assigned (by chance, like flipping a coin) equally to one of the two treatment groups, which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Lubiprostone 24 μg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient
All participants will be asked to take one capsule with breakfast and one capsule with dinner each day throughout the study. All participants will be asked to record each time they have a SBM and all details of each SBM (including the consistency of the stool and the difficulty they have in passing it) in a diary.
This multi-center trial will be conducted in Mexico. The overall time to participate in this study is 8 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation|
|Actual Study Start Date :||May 11, 2016|
|Actual Primary Completion Date :||April 28, 2017|
|Actual Study Completion Date :||June 5, 2017|
Experimental: Lubiprostone 24 μg
Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.
Other Name: AMITIZA
Placebo Comparator: Placebo
Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
Lubiprostone placebo-matching capsules
- Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration [ Time Frame: Week 1 ]A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
- SBM Frequency at Weeks 2, 3 and 4 [ Time Frame: Weeks 2, 3 and 4 ]A SBM is defined as any BM that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
- Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication [ Time Frame: Up to 24 hours after the first dose of study medication ]A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary.
- Mean Degree of Straining Score [ Time Frame: Weeks 1, 2, 3 and 4 ]For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining was scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.
- Mean Degree of Stool Consistency [ Time Frame: Weeks 1, 2, 3 and 4 ]For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).
- Weekly Abdominal Symptoms Score [ Time Frame: Weeks 1, 2, 3 and 4 ]Weekly abdominal symptoms of bloating and discomfort upon waking in the morning was scored weekly on a 5-point scale where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded in the participant in the diary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729909
|Mexicali, Baja California Norte, Mexico|
|Mexico, Distrito Federal, Mexico|
|Cuautitlan Izcalli, Estado De Mexico, Mexico|
|Tlalnepantla, Estado De Mexico, Mexico|
|Leon, Guanajuato, Mexico|
|Morelia, Michoacan, Mexico|
|Monterrey, Nuevo Le0n, Mexico|
|Culiacan, Sinaloa, Mexico|
|Study Director:||Medical Director Clinical Science||Takeda|