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DiarrheaPhase 3NCT02340481

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

A Phase 3 study testing Loperamide hydrochloride + simethicone chewable tablet and Loperamide hydrochloride in people with Diarrhea, run by Xian-Janssen Pharmaceutical Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diarrhea
What is being tested?
Loperamide hydrochloride + simethicone chewable tablet and Loperamide hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
217 participants
Where
4 sitesChina
Study dates
Jul 2005to May 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial
  • Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)
  • Participant's most recently produced stool must be unformed stool
  • Participant must give a positive answer to the following question: "Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour"
  • Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal

Who cannot join

  • Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis
  • Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) or an oral temperature > 38.6 degrees C
  • Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at > 3 per high power field
  • Participant shows a sitting systolic blood pressure less than (<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure < 60 mmHg
  • Participant is unable to take medication orally or tolerate oral rehydration

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Study site

    Beijing

  • Study site

    Guangzhou

  • Study site

    Nanjing

  • Study site

    Shanghai

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Loperamide Hydrochloride/Simethicone Chewable Tablet in the Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

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.

Read the detailed description

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.

Conditions
Diarrhea
Being tested
Loperamide hydrochloride + simethicone chewable tablet, Loperamide hydrochloride, Loperamide hydrochloride + simethicone chewable placebo tablet, Loperamide hydrochloride placebo capsule
Keywords
Diarrhea, Flatulence, Abdominal discomfort, Loperamide hydrochloride, Simethicone, Placebo
Medical subject headings
Diarrhea, Flatulence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loperamide hydrochloride + simethicone chewable tabletDrug

    Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.

  • Loperamide hydrochlorideDrug

    Each capsule contains 2 mg of loperamide hydrochloride

  • Loperamide hydrochloride + simethicone chewable placebo tabletDrug

    Placebo matched to loperamide hydrochloride and simethicone chewable tablet.

  • Loperamide hydrochloride placebo capsuleDrug

    Placebo matched to loperamide hydrochloride capsule.

Study groups in NCT02340481
Study groupRoleWhat they receive
Loperamide Hydrochloride + SimethiconeExperimentalParticipant 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.
Receives: Drug: Loperamide hydrochloride + simethicone chewable tablet; Drug: Loperamide hydrochloride placebo capsule
Loperamide HydrochlorideActive comparatorParticipant 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.
Receives: Drug: Loperamide hydrochloride; Drug: Loperamide hydrochloride + simethicone chewable placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours

  2. Time to Complete Amelioration of Abdominal Discomfort

    The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved.

    Measured: 48 hours

Secondary outcomes (8)

  1. 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.

    Measured: Up to 48 hours

  2. Number of Unformed Stools

    Number of unformed stools produced from first drug administration to the end of treatment.

    Measured: Up to 48 hours

  3. Participant's Evaluation of Treatment Efficacy for Diarrhea at the end of Treatment

    Measured: 48 hours

  4. Number of Participants With Complete Remission of Abdominal Discomfort

    Measured: Up to 48 hours

  5. 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).

    Measured: Up to 48 hours

  6. Participant's Evaluation of Treatment Efficacy for Abdominal Discomfort

    Measured: 48 hours

  7. Participant and Investigator's Overall Evaluations of the Treatment

    Measured: 48 hours

  8. 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.

    Measured: Up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2015 (estimated)
  2. Study startJul 2005
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02340481
Sponsor's protocol ID
CR103534
Other IDs
LOPDIR3001
Status last verified
Jan 2016
First submitted
13 Jan 2015
Last updated
7 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Loperamide hydrochloride + simethicone chewable tablet and Loperamide hydrochloride in people with Diarrhea, run by Xian-Janssen Pharmaceutical Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Last Unformed Stool (TTLUS) (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02340481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.

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