IleusPhase 2NCT05056935
Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus
A Phase 2 study testing LB1148 in people with Ileus, run by Newsoara Biopharma Co., Ltd. at 6 sites in China.
Trial summary
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileus
- What is being tested?
- LB1148
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 6 sitesChina
- Study dates
- 9 Jul 2019to 8 Aug 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo an elective (non-emergent) bowel resection with or without a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
- Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided written informed consent.
Who cannot join
- <18 or >80 years of age.
- Requires emergency bowel surgery.
- Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's Disease, or ulcerative colitis.
- Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.
- American Society of Anesthesiologists (ASA) Class 4 or 5.
- Insulin dependent diabetes mellitus.
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- Known inability to take the study drug orally (i.e. complete small bowel obstruction).
- Has contraindications or potential risk factors to taking tranexamic acid (TXA). These include subjects with:
- Known sensitivity to tranexamic acid (TXA);
- Recent craniotomy (past 30 days);
- Active cerebrovascular bleed;
- Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
- Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction, or
- Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
- Known allergic reaction to polyethylene glycol (PEG) 4000 powder, combination formulation of polyethylene glycol (PEG) and electrolyte powder, polyethylene glycol (PEG) 3350 solution and glucose formulation.
- Has the following risk factors for thromboembolic disease:
- Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:
- Sickle cell disease;
- Nephrotic syndrome;
- Factor V Leiden;
- Prothrombin gene mutation;
- Protein C or S deficiency;
- Antithrombin III deficiency;
- Antiphospholipid syndrome.
- Stage IV malignant neoplasm;
- Neurologic paresis, partial paralysis, or paralysis;
- Pacemaker;
- History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or rental venous/arterial occlusion;
- History of or current seizure disorder.
- Patients with myeloproliferative disorders.
- Body Mass Index (BMI) >40.
- Any other condition that, in the opinion of the Investigator, would preclude the subject from being an appropriate candidate for the study, including severe renal or hepatic impairment.
- Planned treatment with alvimopan (Entereg®) during study participation period.
- Received any other investigational therapy within 4 weeks prior to Randomization
- Chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.
- Female subjects of childbearing potential with a positive urine or serum pregnancy test or who are not taking (or not willing to take) acceptable birth control measures (abstinence, intrauterine devices, contraceptive implants or barrier methods) through Day 30. Additionally, those women who are lactating and insist on breast feeding within 5 days of the last dose of study drug.
- Known history of radiation enteritis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Ningbo First Hospital
Ningbo, Zhejiang
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
General Hospital of Xuzhou Mining Group
Xuzhou, Jiangsu
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus in Subjects Undergoing Elective Bowel Resection
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.
- Conditions
- Ileus
- Being tested
- LB1148, Placebo
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB1148Drug
A total of 700 mL of LB1148 will be administered orally as a split dose before surgery.
PlaceboDrug
A total of 700 mL of placebo will be administered orally as a split dose before surgery.
| Study group | Role | What they receive |
|---|---|---|
| LB1148 | Experimental | active Receives: Drug: LB1148 |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach GI-2
- GI-2 is defined as the toleration of solid food and first bowel movement.
- Ability to tolerate a solid oral diet is defined as the time from the end of surgery (the time of last skin staple or suture is placed by surgeon) to the time a patient finishes first solid meal that requires chewing and no significant nausea or vomiting for 4 hours after solid meal).
- First bowel movement is defined as the time from the end of surgery to the first passage of stool.
Measured: within 14 days after surgery
Secondary outcomes (3)
Time to reach GI-3
- GI-3 is defined as the toleration of solid food and either first flatus or bowel movement.
Measured: within 14 days after surgery
Nausea Verbal Rating Scoring Scale
- To assess the nausea and ability to tolerate food
Measured: within 14 days after surgery
Number of days in the hospital
- Length of Stay (number of days in the hospital, evaluated in hours) will be measured by time to
- Discharge order is written,
- Actual discharge, and
- Standard discharge criteria
Measured: within 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start9 Jul 2019
- Primary completion22 Jul 2020
- Study completion8 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newsoara Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056935
- Sponsor's protocol ID
- LBS-POI-201
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus in Subjects Undergoing Elective Bowel Resection
- ClinicalTrials.gov ID
- NCT05056935
- Acronym / sponsor ID
- LBS-POI-201
- Conditions
- Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Newsoara Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 27 Sep 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.
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LB1148 | Experimental | Drug: LB1148active |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo an elective (non-emergent) bowel resection with or without a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
- Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided written informed consent.
Key exclusion criteria (37 listed)
- <18 or >80 years of age.
- Requires emergency bowel surgery.
- Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's Disease, or ulcerative colitis.
- Note: This does not apply to previous surgery such as hernia repair unrelated to IBD.
- American Society of Anesthesiologists (ASA) Class 4 or 5.
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 |
|---|---|---|
| LB1148A total of 700 mL of LB1148 will be administered orally as a split dose before surgery. | Drug | LB1148 |
| PlaceboA total of 700 mL of placebo will be administered orally as a split dose before surgery. | Drug | Placebo |
Primary outcome
Time to reach GI-2
Time frame: within 14 days after surgery
• GI-2 is defined as the toleration of solid food and first bowel movement. * Ability to tolerate a solid oral diet is defined as the time from the end of surgery (the time of last skin staple or suture is placed by surgeon) to the time a patient finishes first solid meal that requires chewing and no significant nausea or vomiting for 4 hours after solid meal). * First bowel movement is defined as the time from the end of surgery to the first passage of stool.
3 secondary outcomes
Time to reach GI-3
Time frame: within 14 days after surgery
Nausea Verbal Rating Scoring Scale
Time frame: within 14 days after surgery
Number of days in the hospital
Time frame: within 14 days after surgery
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 27 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LB1148 in people with Ileus, run by Newsoara Biopharma Co., Ltd. at 6 sites in China.
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 2 inclusion and 37 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Time to reach GI-2 (time frame: within 14 days after surgery). 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 27 Sep 2021.