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| ID | Type | Description | Link |
|---|---|---|---|
| LOPDIR3001 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group (each group of participants will be treated at the same time), multi-center (when more than one hospital or medical school team work on a medical research study) study. All eligible participants will be randomly assigned to receive either a combination of loperamide hydrochloride and simethicone or loperamide hydrochloride. The study includes Screening Visit (from -24 to 0 hours), Baseline Visit (at 0 hour) and Concluding Visit (within 48 to 96 hours following the start of the trial). The timing of each bowel movement, stool characteristics and the degree and duration of abdominal discomfort caused by gastrointestinal gas accumulation will be recorded for each participant for 48 hours after the first trial drug administration. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loperamide Hydrochloride + Simethicone | Experimental | Participant will take 2 loperamide hydrochloride and simethicone chewable tablets + 2 loperamide hydrochloride placebo capsules orally, as their first dose, and subsequently 1 loperamide hydrochloride and simethicone chewable tablet + 1 loperamide hydrochloride placebo capsule orally, in the event of unformed stool (provided that no more than 4 tablets/capsules are taken within a 24-hour period) up to 48 hours. |
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| Loperamide Hydrochloride | Active Comparator | Participant will take 2 loperamide hydrochloride capsules + 2 loperamide hydrochloride and simethicone chewable placebo tablets orally, as their first dose, and subsequently 1 loperamide hydrochloride capsule + 1 loperamide hydrochloride and simethicone chewable placebo tablet orally, in the event of unformed stool (provided that no more than 4 capsules/tablets are taken within a 24-hour period) up to 48 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loperamide hydrochloride + simethicone chewable tablet | Drug | Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Last Unformed Stool (TTLUS) | The TTLUS is defined as the number of hours from the time the participant first took the trial drug to the last instance of unformed stool, after which the participant only reported formed stool or no stool at all. If no unformed stool was observed at any time during the trial, TTLUS shall be recorded as 0. For participants who withdraw from the trial due to reasons other than complete resolution of the symptoms of diarrhea, TTLUS is defined as the number of hours from the start of the trial to the time of withdrawal. | 48 hours |
| Time to Complete Amelioration of Abdominal Discomfort | The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Remission of Diarrhea | Participants who do not produce any unformed stool within 24 hours of producing their last unformed stool shall be regarded as completely resolved of any diarrhea symptoms. | Up to 48 hours |
| Number of Unformed Stools |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| Loperamide hydrochloride | Drug | Each capsule contains 2 mg of loperamide hydrochloride |
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| Loperamide hydrochloride + simethicone chewable placebo tablet | Drug | Placebo matched to loperamide hydrochloride and simethicone chewable tablet. |
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| Loperamide hydrochloride placebo capsule | Drug | Placebo matched to loperamide hydrochloride capsule. |
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Number of unformed stools produced from first drug administration to the end of treatment. |
| Up to 48 hours |
| Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment | 48 hours |
| Number of Participants With Complete Remission of Abdominal Discomfort | Up to 48 hours |
| Severity of Abdominal Discomfort | Each participant will evaluate any abdominal bloating and/or abdominal pain and/or any other type of abdominal discomfort caused by gastrointestinal gas accumulation occurring within the last hour on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = relatively severe, 4 = severe). | Up to 48 hours |
| Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort | 48 hours |
| Participant and Investigator's Overall Evaluations of the Treatment | 48 hours |
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 48 hours |
| Guangzhou |
| China |
| Nanjing | China |
| Shanghai | China |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D005414 | Flatulence |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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