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Functional ConstipationPhase 2NCT04620161

A Proof of Concept Study of Pradigastat in Patients With Functional Constipation

A Phase 2 study testing Pradigastat Tablets 20mg and Pradigastat Tablets 40mg in people with Functional Constipation, run by Anji Pharma at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of pradigastat 20 and 40 mg as compared to placebo in patients with Functional Constipation. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Functional Constipation
What is being tested?
Pradigastat Tablets 20mg and Pradigastat Tablets 40mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
181 participants
Where
25 sitesin 2 countries
Study dates
22 Sep 2020to 3 Jun 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female patients aged 18 to 70 years of age, inclusive.
  • Patients with FC as defined by the ROME IV diagnostic criteria for FC.
  • Diagnostic criteria for FC:
  • Must include 2 or more of the following:
  • Straining during more than one-fourth (25%) of defecations
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  • Lumpy or hard stools (Bristol Stool Form Scale 1 or 2) more than one-fourth (25%) of defecations
  • Sensation of incomplete evacuation more than one-fourth (25%) of defecations
  • Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations
  • Manual maneuvers to facilitate more than one-fourth (25%) of defecations (such as digital evacuation, or support of the pelvic floor)
  • Fewer than 3 SBMs per week
  • Loose stools are rarely present without the use of laxatives
  • Insufficient criteria for irritable bowel syndrome (IBS). *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
  • Patient has less than 3 SBMs/week within 2 weeks prior to the Screening Visit.
  • Patient has completed a colonoscopy with no clinically significant findings which meet other exclusion criteria within 12 months prior to Screening or at the Screening Visit.
  • Patient must agree that after the Visit 2 (Run-in Visit) they will discontinue any prohibited medications, laxatives (prescription and over-the-counter), supplemental fibers, or traditional medicine taken for abdominal symptoms or constipation as defined per protocol except the rescue medication, provided by the study site and following the Investigator's instructions for its use. Patient should not take rescue medication (bisacodyl) on the calendar day before and the calendar day of the start of the Treatment Period (Visit 3). If the wash-out criteria are not achieved on Visit 3, the Visit could be postponed once.
  • Patient must agree to use and comply with the diet guidance provided in applicable Chronic Constipation Treatment Guideline starting after the Screening Visit and during the study until End of Study.
  • Ability of patient to swallow tablets.
  • A co-operative attitude and ability to perform all study related procedures and to correctly use the diary.

Who cannot join

  • Patient with history of surgical resection of stomach, gallbladder, small intestine, large intestine, and bariatric surgery (excluding resection of appendicitis and benign polyp).
  • Patient with history or current affection of inflammatory bowel disease (Crohn's disease or ulcerative colitis) and celiac disease.
  • Patient with diagnosis of IBS (constipation, diarrhea, or mixed).
  • Patient with history or current ischemic colitis.
  • Patient currently with infectious enteritis or enterocolitis. Patients with asymptomatic diverticulosis, diagnosed during the colonoscopy can be enrolled, unless previous history of diverticulitis.
  • Patient currently with hyperthyroidism or hypothyroidism (unless adequately treated), or patients who have a thyroid-stimulating hormone outside of the laboratory reference range at Visit1.
Show all 34Show fewer
  • Patient with apparent mechanical obstruction (ie, patient with ileus caused by hernia).
  • Patient has a structural abnormality of the GI tract or a disease or history of a condition that can affect GI motility.
  • Patient has ever had any of the following diseases or conditions that can be associated with constipation: pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, and systemic sclerosis.
  • Patient currently affected by constipation due to anorectal disease, affecting the anorectal area such as anal fissure, anorectal fistulas, hemorrhoidal disease Grade III and IV, and bleeding hemorrhoids.
  • Patient currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding, rectal bleeding or heme-positive stool, iron-deficiency anemia or any unexplained anemia, or weight loss) or systemic signs of infection or colitis.
  • Patient currently affected by drug-induced constipation.
  • Patient with constipation due to other organic disease.
  • Patient currently affected by active peptic ulcer (ie, disease that is not adequately treated or stable with therapy).
  • In the case of a female, the one currently affected by endometriosis or uterine adenomyosis.
  • Patient with uncontrolled severe depression, anxiety, or any eating disorder considered by the Investigator to influence drug evaluation.
  • Patient has a potential central nervous system cause of constipation (eg, Parkinson's disease, spinal cord injury, and multiple sclerosis.).
  • Patients with uncontrolled and unstable diabetes mellitus with reported episodes of hypoglycemia within 1 year prior to Screening or history of diabetic neuropathy.
  • Patient with history of abuse of drug or alcohol within 1 year before consent acquisition, or with current abuse.
  • Patient with history of or current diagnosis of any cancer (except for nonmelanoma skin cancer which has been removed) diagnosed less than 5 years prior to Screening. Patients with cancer in full remission more than 5 years after diagnosis are acceptable.
  • Patient with major surgery or any other condition that may require use of narcotic drugs or general anesthesia within 60 days of Screening and during the study.
  • Any clinically significant abnormality identified by physical examination, electrocardiogram (ECG) or laboratory tests, which in the judgment of the Investigator would compromise the patient's safety or successful participation in the clinical study, or any of the following laboratory findings:
  • Male hemoglobin < 12 g/dL (< 120 g/L) and female hemoglobin < 10 g/dL (< 100 g/L) at Screening.
  • Male serum creatinine ≥ 1.5 mg/dL and female serum creatinine ≥ 1.4 mg/dL, or creatinine clearance ≤ 60 mL/min based on calculation using the Cockcroft-Gault formula: ([140-age in years] × weight in kg)/(72 × [creatinine in mg/dL]). For women, multiply result by 0.85.
  • Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase > 2 × upper limit of the normal (ULN) and/or alanine aminotransferase > 2 × ULN and/or total bilirubin > 1.5 × ULN.
  • Patient with stool blood positive at Screening.
  • Patient currently affected by clinically significant cardiovascular disease, respiratory disease, kidney disease, hepatic disease, GI disease (excluding FC), hematology disease, endocrine disease, hemorrhagic disease, or neural/mental disease or other disease or condition that might, in the judgment of the Investigator, place the patients at undue risk or potentially compromise the results of interpretation of the study results.
  • Patient with history of drug allergy to any active or inactive ingredient of pradigastat.
  • Patients who are vegetarian or vegan.
  • Pregnant or nursing (lactating) women.
  • Women of childbearing potential, unless they are using effective methods of contraception during study.
  • Male, who are attempting to naturally father a child or donate sperm.
  • Patients who have received an investigational drug within 30 days or 5 half-lives (whichever is greater) prior to the Screening Visit.
  • Patients participating to another clinical study at any time during this study. Studies that require consent only to store data and that do not require Follow-up are not considered to be observational or interventional and are exempted from this exclusion.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

China20 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510000

  • Sir Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University

    Hangzhou, Zhejiang, 310000

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223000

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313000

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210000

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • Quanzhou First Hospital

    Quanzhou, Fujian, 362000

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200000

  • Ruijin Hopsital

    Shanghai, Shanghai Municipality, 213002

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Siping Central People's Hospital

    Siping, Jilin, 136000

  • Affiliated Hospital of Jiangsu University

    Suzhou, Jiangsu, 215000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

  • Yangzhou First People's Hospital

    Yangzhou, Jiangsu, 225000

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

Other trials in China

United States5 sites

  • Evanston Premier Healthcare Research

    Evanston, Illinois, 60201

  • Jubilee Clinical Research

    Las Vegas, Nevada, 89106

  • Advanced Clinical Research-Meridian

    Meridian, Idaho, 99202

  • PMG Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • Long Island Gastrointestinal Research Group LLP

    New York, New York, 60201

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety and Tolerability of Pradigastat in Patients With Functional Constipation

The purpose of this study is to evaluate the efficacy, safety, and tolerability of pradigastat 20 and 40 mg as compared to placebo in patients with Functional Constipation.

Read the detailed description

This multicenter, randomized, placebo-controlled, double-blind study is designed to demonstrate the efficacy, safety and tolerability of pradigastat relative to placebo across 2 doses (20 and 40 mg) for up to 6 weeks (4-week treatment, 2-week Follow-up) in patients with Functional Constipation.

The primary endpoint is the change from baseline in the number of weekly spontaneous bowel movement (SBM), the key secondary endpoint is the change from baseline in the number of weekly complete spontaneous bowel movement (CSBM).An SBM is defined as a stool not induced by rescue medication, whereas a CSBM is defined as an SBM associated with a sensation of complete evacuation.

Summary of Protocol Amendments:

  • Original Protocol: 06 January 2020
  • Amendment 1: 30 July 2020 (Reason: To respond Health Authority requests)
  • Amendment 2: 05 March 2021 (Reason: Sponsor decided to amend the protocol. Key changes: inclusion/exclusion criteria, criteria for Discountinuation from study/Discontinuation from Study Medication, adding the instruction for evaluating and managing diarrhea AEs. )
Being tested
Pradigastat Tablets 20mg, Pradigastat Tablets 40mg, Pradigastat Tablets 20mg matching Placebo, Pradigastat Tablets 40mg matching Placebo
Keywords
Pradigastat, Proof of Concept, Functional Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pradigastat Tablets 20mgDrug

    Also called ANJ908 20mg

    20mg, once daily, oral administration

  • Pradigastat Tablets 40mgDrug

    Also called ANJ908 40mg

    40mg, once daily, oral administration

  • Pradigastat Tablets 20mg matching PlaceboDrug

    Also called ANJ908 20mg matching Placebo

    once daily, oral administration

  • Pradigastat Tablets 40mg matching PlaceboDrug

    Also called ANJ908 40mg matching Placebo

    once daily, oral administration

Study groups in NCT04620161
Study groupRoleWhat they receive
Pradigastat Tablets 20mgExperimentalThe patients in this arm will receive one tablet a day of Pradigastat 20mg and one tablet a day of Pradigastat 40mg matching placebo
Receives: Drug: Pradigastat Tablets 20mg; Drug: Pradigastat Tablets 40mg matching Placebo
Pradigastat Tablets 40mgExperimentalThe patients in this arm will receive one tablet a day of Pradigastat 40mg and one tablet a day of Pradigastat 20mg matching placebo
Receives: Drug: Pradigastat Tablets 40mg; Drug: Pradigastat Tablets 20mg matching Placebo
PlaceboPlacebo comparatorThe patients in this arm will receive one tablet a day of Pradigastat 20mg matching placebo and one tablet a day of Pradigastat 40mg matching placebo
Receives: Drug: Pradigastat Tablets 20mg matching Placebo; Drug: Pradigastat Tablets 40mg matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of pradigastat in changing the weekly spontaneous bowel movement (SBM) number compared with placebo in patients with functional constipation (FC)

    Number change from baseline in the weekly SBM at Week 4

    Measured: Week 4

Secondary outcomes (5)

  1. Efficacy of pradigastat in changing the weekly complete spontaneous bowel movement (CSBM) number compared with placebo in patients with FC

    Number change from baseline in the weekly CSBM at Week 4

    Measured: Week 4

  2. Safety assessed by incidence of Adverse Events

    Safety assessed by incidence of Adverse Events

    Measured: Each visit through Week 4

  3. Efficacy of pradigastat in changing the responder rate compared with placebo in patients with FC

    Weekly response rate for SBM

    Measured: From baseline to every week until Week 4

  4. Change in weekly score for overall assessment of constipation symptoms and accompanied GI symptoms

    Change in weekly score for overall assessment of constipation symptoms and accompanied GI symptoms (Weekly score includes 10 questions with the range of the total score from 10 to 68, and lower scores mean a better outcome.)

    Measured: From baseline to every week until Week 4

  5. Trough pradigastat plasma concentrations

    Mean plasma pradigastat concentration

    Measured: Week 1 and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start22 Sep 2020
  3. Primary completion30 Apr 2022
  4. Study completion3 Jun 2022

Resources

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
Model description
Randomized, double-blind and placebo-controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04620161
Sponsor's protocol ID
ANJ908C2101
Status last verified
Aug 2022
First submitted
21 Oct 2020
Last updated
24 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pradigastat Tablets 20mg and Pradigastat Tablets 40mg in people with Functional Constipation, run by Anji Pharma at 25 sites in 2 countries.

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 19 inclusion and 34 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China, 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?

Efficacy of pradigastat in changing the weekly spontaneous bowel movement (SBM) number compared with placebo in patients with functional constipation (FC) (time frame: Week 4). 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 NCT04620161.

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 Aug 2022.

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