Constipation - FunctionalTRANSITNCT04887896
Assessing GS500 in Functional Constipation
A study testing GS500 in people with Constipation - Functional, run by Gelesis, Inc..
Trial summary
This study is designed to evaluate the safety, tolerability and efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- GS500
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 30 Dec 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤75 years old
- BMI ≥18.5 and <35 kg/m2
- Rome IV criteria for FC
- Compliant with reporting during Baseline Run-in .
- Ability to record daily bowel habits, including frequency, stool consistency, straining, completeness of evacuation, and patient reported outcomes
- Ability to follow verbal and written instructions
- Consent obtained via signed ICF
Who cannot join
- Meeting Rome IV criteria for IBSat screening
- Missing > 2 days of daily bowel habits reporting during either week of the Baseline Run-in period
- Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Baseline Run-in
- Patients reporting watery stools for any SBM or loose stools for >1 SBM in the absence of laxatives during Baseline Run-in
- Need for routine manual maneuvers in the last 6 months in order to achieve a BM
- History of significant GI lumen surgery at any time or other GI or abdominal surgery except cholecystectomy or appendectomy within 2 months prior to screening
Show all 26Show fewer
- Documented GI obstruction
- History of laxative abuseas judged by investigator team
- Glycosylated hemoglobin (HbA1c) ≥8.5%
- Known history of Crohn's disease or ulcerative colitis
- Pregnancy in females of childbearing potential or lactation
- Absence of medically approved contraception in females of childbearing potential
- History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, HPMC, pectin, gelatin, maltotextrin or titanium dioxide
- Currently enrolled in another investigational device or drug study, or less than 3 months since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
- Subjects anticipating surgical intervention during the study
- Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- History of swallowing disorders
- History of gastroparesis
- History of intestinal stricture (e.g., Crohn's disease)
- History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
- History of maltodextrin intolerance
- Presence of metastatic cancer or current use of systemic anti-cancer treatments
- Anticipated requirement for use of prohibited concomitant medications
- Current use of prescribed or illicit opioids
- Use of intestinal secretagogues to treat constipation/IBS within 12 months of the screening visit
- Any other clinically significant disease or biochemical abnormality interfering with the assessments of GS500, according to the Investigator
Trial locations and contacts
No sites are listed yet.
Henry W Calderon, BS contact
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS500 in Subjects With Functional Constipation
This study is designed to evaluate the safety, tolerability and efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
Read the detailed description
To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
- Conditions
- Constipation - Functional
- Being tested
- GS500, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS500Device
Device: GS500
PlaceboDevice
Device: Placebo
| Study group | Role | What they receive |
|---|---|---|
| GS500 flexible dose | Experimental | 3, 2, or 4 GS500 capsules 2 times per day Receives: Device: GS500 |
| Placebo flexible dose | Placebo comparator | 3, 2, or 4 placebo capsules 2 times per day Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Proportion of CSBM Responders defined as subjects with increase of ≥ 1 CSBM from Baseline Run-In during at least 6 of the 8 weeks of the Effectiveness period
Measured: 8 weeks
Secondary outcomes (6)
Straining score (EoPS)
Measured: 8 weeks
Constipation severity (self-assessment on 0 to 10 numerical rating scale)
Measured: 8 weeks
SBM stool consistency (BSFS)
Measured: 8 weeks
SBM frequency rate (SBMs/week)
Measured: 8 weeks
CSBM frequency rate (CSBMs/week)
Measured: 8 weeks
Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start15 Jul 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887896
- Sponsor's protocol ID
- GS-500-001
- Acronym
- TRANSIT
- Status last verified
- Jan 2022
- First submitted
- 11 May 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS500 in Subjects With Functional Constipation
- ClinicalTrials.gov ID
- NCT04887896
- Acronym / sponsor ID
- TRANSIT / GS-500-001
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 May 2021 (actual)
- 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 study is designed to evaluate the safety, tolerability and efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
Detailed description
To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.
| Arm | Type | Receives |
|---|---|---|
| GS500 flexible dose | Experimental | Device: GS5003, 2, or 4 GS500 capsules 2 times per day |
| Placebo flexible dose | Placebo comparator | Device: Placebo3, 2, or 4 placebo capsules 2 times per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 and ≤75 years old
- BMI ≥18.5 and <35 kg/m2
- Rome IV criteria for FC
- Compliant with reporting during Baseline Run-in .
- Ability to record daily bowel habits, including frequency, stool consistency, straining, completeness of evacuation, and patient reported outcomes
Key exclusion criteria (26 listed)
- Meeting Rome IV criteria for IBSat screening
- Missing > 2 days of daily bowel habits reporting during either week of the Baseline Run-in period
- Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Baseline Run-in
- Patients reporting watery stools for any SBM or loose stools for >1 SBM in the absence of laxatives during Baseline Run-in
- Need for routine manual maneuvers in the last 6 months in order to achieve a BM
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 |
|---|---|---|
| GS500Device: GS500 | Device | GS500 flexible dose |
| PlaceboDevice: Placebo | Device | Placebo flexible dose |
Primary outcome
Primary Endpoint
Time frame: 8 weeks
Proportion of CSBM Responders defined as subjects with increase of ≥ 1 CSBM from Baseline Run-In during at least 6 of the 8 weeks of the Effectiveness period
6 secondary outcomes
Straining score (EoPS)
Time frame: 8 weeks
Constipation severity (self-assessment on 0 to 10 numerical rating scale)
Time frame: 8 weeks
SBM stool consistency (BSFS)
Time frame: 8 weeks
SBM frequency rate (SBMs/week)
Time frame: 8 weeks
CSBM frequency rate (CSBMs/week)
Time frame: 8 weeks
Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Henry W Calderon, BS contact
Questions about this trial
What is this clinical trial studying?
A study testing GS500 in people with Constipation - Functional, run by Gelesis, Inc..
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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan M Heshmati, MD ((215) 275 - 1275, hheshmati@gelesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 8 weeks). 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 Jan 2022.