Chronic ConstipationPhase 2NCT01523184
A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
A Phase 2 study testing YKP10811 Drug Product Capsule in people with Chronic Constipation and Functional Constipation, run by SK Life Science, Inc. at 1 site in United States.
Trial summary
This will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Constipation, Functional Constipation
- What is being tested?
- YKP10811 Drug Product Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Nov 2013
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.) for at least 6 months prior to Day 1 of the study
- Body Mass Index of 19 through 40 kg/m2
- Participants must be willing to follow dietary restrictions
- Females of childbearing potential (ie, not menopausal, no hysterectomy, no bilateral oophorectomy) must complete a negative pregnancy test (urine) prior to receiving any radioisotopes
- No evidence of pelvic floor dysfunction
- If clinically indicated, absence of an evacuation disorder should be confirmed within 30 days prior to the first dose of study medication
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- At Screening, patients must meet ROME III Criteria for FC, which assumes an absence of a structural or biochemical explanation
- The patient's screening (baseline) colonic transit test must show a GC ≤ 2.4 at 24 hours; and
- Baseline EKG shows QTc interval ≤ 450mSec
Who cannot join
- History of clinically-significant manifestations or current abnormality of any organ system
- History of inflammatory bowel disease
- Any history of GI surgery within 6 months prior to the first dose of study medication
- History of clinically-significant prolonged diarrhea, in the absence of a laxative
- Patients who have started a special dietary habit and/or an intense physical workout program within 4 weeks prior to the first dose of study medication
- Any clinically-significant surgical procedure within 30 days prior to the first dose of study medication
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- History of alcoholism or drug addiction within 12 months prior to the first dose of study medication
- Any patient who has had an acute illness within 5 days prior to the first dose of study medication, eg, flu syndrome, GI virus, indigestion
- Patients who are breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single-Center, Randomized, Parallel Group, Multiple Administration, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
This will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Four groups including a placebo group will be enrolled and will receive multiple oral doses of YKP10811 or matching placebo.
Read the detailed description
If the participant fulfills the initial eligibility criteria, the patient will be randomized to 1 of the active treatment groups or placebo. During the treatment period, patients will receive study medication once daily for 8 days. Patients will undergo scintigraphic assessment of gastric, small bowel and colonic transit of solids over the 48-hour period.
Patients will be males or females, 18 through 65 years of age with a body mass index (BMI) of 19 through 40 kg/m2, with Chronic Constipation or Functional Constipation and no evidence of evacuation disorder as assessed by the Investigator and meet all the inclusion criteria and none of the exclusion criteria.
- Conditions
- Chronic Constipation, Functional Constipation
- Being tested
- Placebo Capsule, YKP10811 Drug Product Capsule
- Keywords
- Chronic constipation (CC), Functional Constipation (FC), Gastric Emptying, Colon Transit, multiple doses of YKP10811, gastrointestinal transit, colonic transit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo CapsuleDrug
This is the placebo capsule
YKP10811 Drug Product CapsuleDrug
The drug product, YKP10811, 10 mg under investigation
YKP10811 Drug Product CapsuleDrug
The drug product, YKP10811, 20 mg under investigation
YKP10811 Drug Product CapsuleDrug
The drug product, YKP10811, 30 mg under investigation
| Study group | Role | What they receive |
|---|---|---|
| Placebo Capsule | Placebo comparator | Placebo Capsules Receives: Drug: Placebo Capsule |
| YKP10811 Drug Product Capsule, 10 mg | Active comparator | Not described Receives: Drug: YKP10811 Drug Product Capsule |
| YKP10811 Drug Product Capsule, 20 mg | Active comparator | Not described Receives: Drug: YKP10811 Drug Product Capsule |
| YKP10811 Drug Product Capsule, 30 mg | Active comparator | Not described Receives: Drug: YKP10811 Drug Product Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Geometric Center (GC) at 24 hours
The colonic GC at 24 hours is the measurement of the move of the food within the GI track.
Measured: 48 hours
Secondary outcomes (1)
Gastric emptying half time
The gastric emptying half time is the time to empty the half of the ingested solid food in the stomach.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523184
- Sponsor's protocol ID
- YKP10811C003
- Status last verified
- Jul 2014
- First submitted
- 27 Jan 2012
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shin A, Acosta A, Camilleri M, Boldingh A, Burton D, Ryks M, Rhoten D, Zinsmeister AR. A randomized trial of 5-hydroxytryptamine4-receptor agonist, YKP10811, on colonic transit and bowel function in functional constipation. Clin Gastroenterol Hepatol. 2015 Apr;13(4):701-8.e1. doi: 10.1016/j.cgh.2014.08.012. Epub 2014 Aug 19.
PubMed 25148765
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Center, Randomized, Parallel Group, Multiple Administration, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
- ClinicalTrials.gov ID
- NCT01523184
- Acronym / sponsor ID
- YKP10811C003
- Conditions
- Chronic Constipation, Functional Constipation
- Keywords
- Chronic constipation (CC), Functional Constipation (FC), Gastric Emptying, Colon Transit, multiple doses of YKP10811, gastrointestinal transit, colonic transit
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Feb 2012 (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 will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Four groups including a placebo group will be enrolled and will receive multiple oral doses of YKP10811 or matching placebo.
Detailed description
If the participant fulfills the initial eligibility criteria, the patient will be randomized to 1 of the active treatment groups or placebo. During the treatment period, patients will receive study medication once daily for 8 days. Patients will undergo scintigraphic assessment of gastric, small bowel and colonic transit of solids over the 48-hour period.
Patients will be males or females, 18 through 65 years of age with a body mass index (BMI) of 19 through 40 kg/m2, with Chronic Constipation or Functional Constipation and no evidence of evacuation disorder as assessed by the Investigator and meet all the inclusion criteria and none of the exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Capsule | Placebo comparator | Drug: Placebo CapsulePlacebo Capsules |
| YKP10811 Drug Product Capsule, 10 mg | Active comparator | Drug: YKP10811 Drug Product Capsule |
| YKP10811 Drug Product Capsule, 20 mg | Active comparator | Drug: YKP10811 Drug Product Capsule |
| YKP10811 Drug Product Capsule, 30 mg | Active comparator | Drug: YKP10811 Drug Product Capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.) for at least 6 months prior to Day 1 of the study
- Body Mass Index of 19 through 40 kg/m2
- Participants must be willing to follow dietary restrictions
- Females of childbearing potential (ie, not menopausal, no hysterectomy, no bilateral oophorectomy) must complete a negative pregnancy test (urine) prior to receiving any radioisotopes
- No evidence of pelvic floor dysfunction
Key exclusion criteria (9 listed)
- History of clinically-significant manifestations or current abnormality of any organ system
- History of inflammatory bowel disease
- Any history of GI surgery within 6 months prior to the first dose of study medication
- History of clinically-significant prolonged diarrhea, in the absence of a laxative
- Patients who have started a special dietary habit and/or an intense physical workout program within 4 weeks prior to the first dose of study medication
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 |
|---|---|---|
| Placebo CapsuleThis is the placebo capsule | Drug | Placebo Capsule |
| YKP10811 Drug Product CapsuleThe drug product, YKP10811, 10 mg under investigation | Drug | YKP10811 Drug Product Capsule, 10 mg |
| YKP10811 Drug Product CapsuleThe drug product, YKP10811, 20 mg under investigation | Drug | YKP10811 Drug Product Capsule, 20 mg |
| YKP10811 Drug Product CapsuleThe drug product, YKP10811, 30 mg under investigation | Drug | YKP10811 Drug Product Capsule, 30 mg |
Primary outcome
Colonic Geometric Center (GC) at 24 hours
Time frame: 48 hours
The colonic GC at 24 hours is the measurement of the move of the food within the GI track.
1 secondary outcome
Gastric emptying half time
Time frame: 4 hours
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 4 Jul 2014.
- Derived from this study: PubMed 25148765Shin A, Acosta A, Camilleri M, Boldingh A, Burton D, Ryks M, Rhoten D, Zinsmeister AR. A randomized trial of 5-hydroxytryptamine4-receptor agonist, YKP10811, on colonic transit and bowel function in functional constipation. Clin Gastroenterol Hepatol. 2015 Apr;13(4):701-8.e1. doi: 10.1016/j.cgh.2014.08.012. Epub 2014 Aug 19.
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YKP10811 Drug Product Capsule in people with Chronic Constipation and Functional Constipation, run by SK Life Science, Inc. at 1 site in United States.
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 9 inclusion and 9 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 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Colonic Geometric Center (GC) at 24 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01523184, which also lists 1 linked publication.
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 4 Jul 2014.