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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01993875
Other study ID # SCMP-0211-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2013
Est. completion date January 2014

Study information

Verified date July 2015
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Medically-confirmed diagnosis of chronic idiopathic constipation

- Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study

- Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

Exclusion Criteria:

- Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.

- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lubiprostone
Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
Placebo
Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Mallinckrodt Sucampo AG, Sucampo Pharma Americas, LLC, Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Spontaneous Bowel Movements (SBMs) Within 1 Week SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. within 1 week
Secondary Consistency of SBMs at Week 1 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. at Week 1
Secondary Overall Stool Consistency at Week 1 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. at Week 1
Secondary Mean Change From Baseline in Stool Consistency at Week 1 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). Baseline and Week 1
Secondary Overall Straining at Week 1 Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). Week 1
Secondary Mean Change From Baseline in Straining at Week 1 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. Week 1
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