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

Shandong Luoxin Pharmaceutical Group

Status and phase: Completed; Phase 3

Conditions: Functional Constipation

Treatments: Drug: Plecanatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05151328

NC011901

Details and patient eligibility

About

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.

Enrollment: 648 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Males or females over 18 years of age (inclusive) when signed the （Inform Consent Form)ICF.
3. Patient agrees to use adequate medical contraception from signing of informed consent through 28 days after the first dose of study drug
4. Colonoscopy with normal or mildly abnormal results.
5. 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:
6. 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.
7. 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.
8. 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.

Exclusion criteria

1. Previous use of Plecanatide.
2. Previous anaphylactic reaction to any medication.
3. Females are excluded if lactating.
4. Patient has unexplained and clinically significant "alarm symptoms" including nonhemorrhoidal lower Gastrointestinal (GI) bleeding, iron-deficiency anemia, weight loss.
5. Patient with known constipation due to secondary causes.
6. Patient had a known structural abnormality of the gastrointestinal tract or a condition that may affect gastrointestinal motility or defecation
7. Patient had a history of chronic disease with abdominal pain or discomfort that would interfere with the evaluation of this study
8. Patient has active peptic ulcer.
9. Patient has had or is scheduled to have abdominal surgery during the study.
10. Patient has fecal impaction requiring hospitalization or emergency room treatment.
11. Patient has traveled to a region considered as high risk for developing traveler's diarrhea while participating in the study.
12. 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.
13. Known or suspected alcoholism or drug addiction or significant drug abuse within 1 year of the Screening visit.
14. Patient has a history of diabetic neuropathy.
15. Patient has hypothyroidism.
16. Patient has active HBV、HCV or HIV antibody positive.
17. Patient with severe cardiopulmonary or other organ dysfunction.
18. Patient with significant abnormalities in physical examination, ECG, or laboratory tests that, in the judgment of the investigator, would make the patient inappropriate for this study.
19. Evaluation of BSFS not met before administration。
20. Patient uses Dulcolax® within 72 hours before the first dose of study drug.
21. Patient reports the use of rescue medication (Dulcolax®). for ≥3 days in either of the two weeks in the Pre-Treatment Assessment period.
22. Use of concomitant medications not allowed by the protocol prior to randomization。
23. Hospitalization for psychiatric disorder or suicide attempt within 2 years before the screening visit。
24. Patient reports participation in a clinical study within 30 days of the Screening visit or Five half-lives prior to visit 1.
25. Other circumstances in which the investigator considers the subject inappropriate for study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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648 participants in 2 patient groups, including a placebo group

Plecanatide group(n=320)

Experimental group

Description:

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.

Treatment:

Drug: Plecanatide

Placebo group (n=320)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Plecanatide