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

NCT04620161 | Completed Phase 2 FDA Drug

• 1 other identifier: ANJ908C2101
• Study Type: interventional
• Target: 181
• Locations: 2 countries
• Sites: 25

Brief 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.

Conditions

Functional Constipation

Keywords

Pradigastat; Proof of Concept; Functional Constipation

Outcome Measures

Primary Outcomes (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

  Week 4

Secondary Outcomes (5)

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

  Week 4

• Safety assessed by incidence of Adverse Events

  Each visit through Week 4

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

  From baseline to every week until Week 4

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

  From baseline to every week until Week 4

• Trough pradigastat plasma concentrations

  Week 1 and Week 4

Study Arms (3)

Pradigastat Tablets 20mg

EXPERIMENTAL

The patients in this arm will receive one tablet a day of Pradigastat 20mg and one tablet a day of Pradigastat 40mg matching placebo

Drug: Pradigastat Tablets 20mg; Drug: Pradigastat Tablets 40mg matching Placebo

Pradigastat Tablets 40mg

EXPERIMENTAL

The patients in this arm will receive one tablet a day of Pradigastat 40mg and one tablet a day of Pradigastat 20mg matching placebo

Drug: Pradigastat Tablets 40mg; Drug: Pradigastat Tablets 20mg matching Placebo

Placebo

PLACEBO COMPARATOR

The 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

Drug: Pradigastat Tablets 20mg matching Placebo; Drug: Pradigastat Tablets 40mg matching Placebo

Interventions

Pradigastat Tablets 20mg DRUG

20mg, once daily, oral administration

Also known as: ANJ908 20mg

Pradigastat Tablets 20mg

Pradigastat Tablets 40mg DRUG

40mg, once daily, oral administration

Also known as: ANJ908 40mg

Pradigastat Tablets 40mg

Pradigastat Tablets 20mg matching Placebo DRUG

once daily, oral administration

Also known as: ANJ908 20mg matching Placebo

Placebo; Pradigastat Tablets 40mg

Pradigastat Tablets 40mg matching Placebo DRUG

once daily, oral administration

Also known as: ANJ908 40mg matching Placebo

Placebo; Pradigastat Tablets 20mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Anji Pharma: lead
• Covance: collaborator

Study Sites (25)

Advanced Clinical Research-Meridian

Meridian, Idaho, 99202, United States

Location

Evanston Premier Healthcare Research

Evanston, Illinois, 60201, United States

Location

Jubilee Clinical Research

Las Vegas, Nevada, 89106, United States

Location

Long Island Gastrointestinal Research Group LLP

New York, New York, 60201, United States

Location

PMG Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Quanzhou First Hospital

Quanzhou, Fujian, 362000, China

Location

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, 510000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Huai'an First People's Hospital

Huai'an, Jiangsu, 223000, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Affiliated Hospital of Jiangsu University

Suzhou, Jiangsu, 215000, China

Location

Yangzhou First People's Hospital

Yangzhou, Jiangsu, 225000, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Siping Central People's Hospital

Siping, Jilin, 136000, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Ruijin Hopsital

Shanghai, Shanghai Municipality, 213002, China

Location

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

Hangzhou, Zhejiang, 310000, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, 313000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

pradigastat

Study Officials

• Dan Meyers, M.D.

  Anji Pharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind and placebo-controlled study

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 6, 2020
• Study Start: September 22, 2020
• Primary Completion: April 30, 2022
• Study Completion: June 3, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

CN (20); US (5)