Constipation - Functional
Conditions
Brief summary
This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year
Interventions
DRUGLubiprostone
12 or 24 mcg soft capsules for oral administration
Sponsors
Takeda
Sucampo Pharma Americas, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Has completed the 3-month placebo-controlled study (NCT02042183) * Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility
Exclusion criteria
* Has untreated faecal impaction at the time of rolling over into study * Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease * Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | within 9 months | Spontaneous bowel movements are defined as bowel movements without the aid of drugs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | within 9 months | Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse. |
| Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | within 9 months | Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome. |
| Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | within 9 months | Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome. |
Countries
Belgium, Canada, France, Netherlands, Poland, United Kingdom, United States
Participant flow
Recruitment details
Participants who completed the 3-month placebo-controlled study (NCT02042183) were invited to enroll in this safety extension study lasting an additional 9 months.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants receive lubiprostone | 418 |
| Total | 418 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Lack of Efficacy | 35 |
| Overall Study | Lost to Follow-up | 32 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 36 |
| Overall Study | Withdrawn by Sponsor | 5 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Customized 6-17 years of age | 418 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 2 participants | — |
| Region of Enrollment France | 1 participants | — |
| Region of Enrollment Netherlands | 36 participants | — |
| Region of Enrollment Poland | 10 participants | — |
| Region of Enrollment United Kingdom | 10 participants | — |
| Region of Enrollment United States | 359 participants | — |
| Sex: Female, Male Female | 229 Participants | — |
| Sex: Female, Male Male | 189 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 419 |
| other Total, other adverse events | 147 / 419 |
| serious Total, serious adverse events | 13 / 419 |
Outcome results
Primary
Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
Time frame: within 9 months
Population: mITT with evaluable data at the given time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 1 | 2.66 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 2 | 2.75 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 3 | 2.70 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 4 | 2.75 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 5 | 2.74 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 6 | 2.50 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 7 | 2.63 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 8 | 2.63 Weekly SBMs |
| All Participants | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Month 9 | 2.50 Weekly SBMs |
Other Pre-specified
Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain
Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.
Time frame: within 9 months
Population: mITT with evaluable data at the given time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 1 | 1.00 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 2 | 0.99 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 3 | 0.90 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 4 | 0.85 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 5 | 0.84 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 6 | 0.82 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 7 | 0.75 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 8 | 0.85 score on a scale |
| All Participants | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Month 9 | 0.79 score on a scale |
Other Pre-specified
Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs
Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.
Time frame: within 9 months
Population: mITT with evaluable data at the given time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 1 | 1.19 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 2 | 1.25 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 3 | 1.14 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 4 | 1.17 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 5 | 1.19 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 6 | 1.13 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 7 | 1.00 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 8 | 1.00 score on a scale |
| All Participants | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Month 9 | 1.00 score on a scale |
Other Pre-specified
Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs
Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.
Time frame: within 9 months
Population: mITT with evaluable data at the given time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 8 | 2.90 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 1 | 2.80 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 2 | 2.75 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 3 | 2.78 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 4 | 2.78 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 5 | 2.83 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 6 | 2.83 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 7 | 2.87 score on a scale |
| All Participants | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Month 9 | 2.89 score on a scale |