Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation

NCT05151328 | Completed Phase 3

• 1 other identifier: NC011901
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, double-blind, Placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Plecanatide in the treatment of Functional Constipation in Chinese patients for up to 12 weeks. Patients will enter a Screening period which must undergo a 2-week Pre-Treatment assessment, they will complete daily assessments of electronic dairy to demonstrate the eligibility. Eligible subjects will be randomized into Plecanatide 3 mg group or Placebo group at Visit 1 at the ratio of 1:1 and take an oral dose of study treatment continuously for 12 weeks. For 2 weeks after complete dosing patients will continue to complete daily electronic dairy. Patients will then return to the clinical site for efficacy and safety assessment as part of an End of Study visit. The planned duration of participation in this study will be 154 days and up to 164 days with all windows considered.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• Number of Durable Overall CSBM Responders, Mean Replacement Approach

  The primary efficacy endpoint will be the proportion of patients who are overall Complete spontaneous bowel movement (CSBM) responders during the 12-week Treatment Period. A CSBM weekly responder is defined as a patient who has ≥ 3 CSBMs per week and an increase from baseline of ≥ 1 CSBM for that week. An overall CSBM responder is a patient who is a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.

  12-Week Treatment Period

Secondary Outcomes (13)

• Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach

  Baseline and 12 weeks

• Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach

  Baseline and 12 weeks

• Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach

  Baseline and 12 weeks

• Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach

  Baseline and 12 weeks

• Treatment Satisfaction

  Baseline and 12 weeks

Other Outcomes (1)

• Safety Endpoints

  Baseline and 12 weeks

Study Arms (2)

Plecanatide group(n=320)

EXPERIMENTAL

The investigational products are administrated orally, each patient will take one table (Plecanatide 3.0mg) Once daily(QD) in the day before 18:00 with approximately of water. If the investigational product is not taken in the day before 18:00 then skip the dose on that day and take the next dose on the next regular time. The duration of treatment is 12 weeks.

Drug: Plecanatide

Placebo group (n=320)

PLACEBO COMPARATOR

The investigational products are administrated orally, each patient will take one table (Placebo 3mg) QD in the day before 18:00 with approximately of water. If the investigational product is not taken in the day before 18:00 then skip the dose on that day and take the next dose on the next regular time. The duration of treatment is 12 weeks.

Drug: Plecanatide

Interventions

Plecanatide DRUG

Plecanatide or Placebo; Route of Plecanatide/placebo administration: tablet; dosage: 3mg, dosage form oral; Frequency of administration: QD

Also known as: Placebo

Placebo group (n=320); Plecanatide group(n=320)

Eligibility Criteria

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

You may qualify if:

• Patient is willing and able to participate in the study for the required duration, can understand and is willing to sign the （Inform Consent Form)ICF and agrees to undergo all protocol-related tests and procedures.
• Males or females over 18 years of age (inclusive) when signed the （Inform Consent Form)ICF.
• Patient agrees to use adequate medical contraception from signing of informed consent through 28 days after the first dose of study drug
• Colonoscopy with normal or mildly abnormal results.
• Patient meets the Rome Ⅳ functional constipation criteria as modified for this study for at least 3 months prior to the Screening visit with symptom onset for at least 6 months prior to the diagnosis. The Rome Ⅳ criteria as modified for this study require the following:
• Patients who meet the modified Rome Ⅳ criteria based on history must also demonstrate the following during the two-week Pre-Treatment Electronic hand-held device(EHD) assessment period.
• Patient must complete at least 6 of the 7 daily (Electronic Diary) eDiary entries during each week of the 2-week pre-treatment assessment period.
• Patient is able to communicate with Investigator and understand and comply with scheduled visits, study treatment, laboratory tests, and other study-related procedures and requirements during the study.

You may not qualify if:

• Previous use of Plecanatide.
• Previous anaphylactic reaction to any medication.
• Females are excluded if lactating.
• Patient has unexplained and clinically significant "alarm symptoms" including nonhemorrhoidal lower Gastrointestinal (GI) bleeding, iron-deficiency anemia, weight loss.
• Patient with known constipation due to secondary causes.
• Patient had a known structural abnormality of the gastrointestinal tract or a condition that may affect gastrointestinal motility or defecation
• Patient had a history of chronic disease with abdominal pain or discomfort that would interfere with the evaluation of this study
• Patient has active peptic ulcer.
• Patient has had or is scheduled to have abdominal surgery during the study.
• Patient has fecal impaction requiring hospitalization or emergency room treatment.
• Patient has traveled to a region considered as high risk for developing traveler's diarrhea while participating in the study.
• Patient has a history of cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in a complete remission without maintenance chemotherapy for at least 5 years prior to the Screening visit.
• Known or suspected alcoholism or drug addiction or significant drug abuse within 1 year of the Screening visit.
• Patient has a history of diabetic neuropathy.
• Patient has hypothyroidism.

Sponsors & Collaborators

• Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Interventions

plecanatide

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 9, 2021
• Study Start: March 18, 2022
• Primary Completion: October 12, 2023
• Study Completion: October 26, 2023
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)