Chronic ConstipationPhase 3NCT02961556
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
A Phase 3 study testing AJG555 in people with Chronic Constipation, run by EA Pharma Co., Ltd. at 11 sites in Japan.
Trial summary
This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- AJG555
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 11 sitesJapan
- Study dates
- 15 Nov 2016to 4 Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Main Inclusion Criteria:
- Participants with chronic constipation
- Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)
- Gender: N/A
Who cannot join
- Main Exclusion Criteria:
- Participants with organic constipation or participants suspected of having organic constipation
- Participants with symptomatic constipation or participants suspected of having symptomatic constipation
- Participants with drug-induced constipation or participants suspected of having drug-induced constipation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
EA Pharma Trial Site #1
Bunkyo, Tokyo
EA Pharma Trial Site #1
Hiroshima
EA Pharma Trial Site #1
Hutyu, Tokyo
EA Pharma Trial Site #1
Ōta-ku, Tokyo
EA Pharma Trial Site #1
Saitama
EA Pharma Trial Site #1
Setagaya City, Tokyo
EA Pharma Trial Site #2
Setagaya City, Tokyo
EA Pharma Trial Site #1
Shinjuku, Tokyo
EA Pharma Trial Site #2
Shinjuku, Tokyo
EA Pharma Trial Site #1
Yokohama, Kanagawa
EA Pharma Trial Site #2
Yokohama, Kanagawa
About this study
This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.
- Conditions
- Chronic Constipation
- Being tested
- AJG555
- Keywords
- AJG555, Constipation, Phase 3, Pediatric participants
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJG555Drug
Participants will receive 1 to 6 sachets daily per participants' age and conditions.
| Study group | Role | What they receive |
|---|---|---|
| AJG555 | Experimental | After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks. Receives: Drug: AJG555 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period
Measured: Screening; Week 2 of administration period
Secondary outcomes (11)
Change from the second week of the screening period in the number of SBMs at each week of the administration period
Measured: Screening; up to Week 12 of administration period
Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period
Measured: Screening; up to Week 12 of administration period
Change from the screening period in the number of SBMs at two weeks after the initiation of the administration
Measured: Screening; Week 2
Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration
Measured: Screening; Week 2 of administration period
Number of days until SBM and CSBM
Measured: up to Week 12 of administration period
Change from the second week of the screening period in the total number of SBMs at each week of the administration period
Measured: Screening; up to Week 12 of administration period
Percentage of responders for SBM and CSBM at each week of the administration period
Measured: up to Week 12 of administration period
Stool consistency measured by the Bristol stool form scale
Measured: up to Week 12 of administration period
Usage of rescue medication
Measured: up to Week 12 of administration period
Number of pouches of AJG555 administered
Measured: up to Week 12 of administration period
Duration of administration of AJG555
Measured: up to Week 12 of administration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start15 Nov 2016
- Primary completion9 Jun 2017
- Study completion4 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961556
- Sponsor's protocol ID
- AJG555/CT2
- Status last verified
- Oct 2017
- First submitted
- 9 Nov 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT02961556
- Acronym / sponsor ID
- AJG555/CT2
- Conditions
- Chronic Constipation
- Keywords
- AJG555, Constipation, Phase 3, Pediatric participants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AJG555 | Experimental | Drug: AJG555After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants with chronic constipation
- Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)
- Gender: N/A
Key exclusion criteria (4 listed)
- Participants with organic constipation or participants suspected of having organic constipation
- Participants with symptomatic constipation or participants suspected of having symptomatic constipation
- Participants with drug-induced constipation or participants suspected of having drug-induced constipation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AJG555Participants will receive 1 to 6 sachets daily per participants' age and conditions. | Drug | AJG555 |
Primary outcome
Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period
Time frame: Screening; Week 2 of administration period
11 secondary outcomes
Change from the second week of the screening period in the number of SBMs at each week of the administration period
Time frame: Screening; up to Week 12 of administration period
Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period
Time frame: Screening; up to Week 12 of administration period
Change from the screening period in the number of SBMs at two weeks after the initiation of the administration
Time frame: Screening; Week 2
Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration
Time frame: Screening; Week 2 of administration period
Number of days until SBM and CSBM
Time frame: up to Week 12 of administration period
Change from the second week of the screening period in the total number of SBMs at each week of the administration period
Time frame: Screening; up to Week 12 of administration period
Percentage of responders for SBM and CSBM at each week of the administration period
Time frame: up to Week 12 of administration period
Stool consistency measured by the Bristol stool form scale
Time frame: up to Week 12 of administration period
Usage of rescue medication
Time frame: up to Week 12 of administration period
Number of pouches of AJG555 administered
Time frame: up to Week 12 of administration period
Duration of administration of AJG555
Time frame: up to Week 12 of administration period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AJG555 in people with Chronic Constipation, run by EA Pharma Co., Ltd. at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period (time frame: Screening; Week 2 of administration period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.