Trials / Unknown
UnknownNCT04804267
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Clinical Equivalence of Two Linaclotide Products and the Efficacy and Safety of the Test Formulation of Linaclotide in the Treatment of Chronic Idiopathic Constipation
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the clinical equivalence of the test formulation of Linaclotide compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation, and to evaluate the efficacy and safety of the test formulation of Linaclotide in the treatment of Chronic Idiopathic Constipation.
Detailed description
This is a randomized, double-blinded, placebo-controlled, multicenter study to evaluate the clinical equivalence of the test formulation of Linaclotide (manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd.) compared to the marketed formulation LINZESS® in patients with Chronic Idiopathic Constipation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linaclotide | Manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd. Drug: Linaclotide 145μg orally once daily |
| DRUG | LINZESS® | Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily |
| DRUG | Placebo | Drug: Placebo orally once daily |
Timeline
- Start date
- 2021-03-05
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
- First posted
- 2021-03-18
- Last updated
- 2021-03-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04804267. Inclusion in this directory is not an endorsement.