Irritable Bowel SyndromePhase 2NCT01027260
Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation
A Phase 2 study testing Itopride HCI 50 mg and Itopride HCI 100 mg in people with Irritable Bowel Syndrome, run by Abbott at 4 sites in Pakistan.
Trial summary
Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Itopride HCI 50 mg and Itopride HCI 100 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 4 sitesPakistan
- Study dates
- Jun 2008to Sep 2010
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patient fulfilling the Rome III criteria for IBS-C
- Signed informed consent at screening visit
Who cannot join
- Patients having significant diarrhea at least 25% of the time during the past 3 months
- Patients having alarm symptoms or signs
- Chronic diarrhea
- History of gastrointestinal haemorrhage, mechanical obstruction or perforation
- Patient with clinically relevant ECG abnormalities (prolonged QT interval)
- Active psychiatric disorder that would interfere with the study objectives
Show all 12Show fewer
- Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient
- Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine * 2 mg/dl [177 µmol/l] according to the medical judgement of the investigator
- Patient with hypokalemia (serum potassium < 3.5 mmol/l).
- History of any known hypersensitivity to the ingredients of the investigational drug
- Pregnancy or lactation
- Women with childbearing potential who do not apply a medically accepted method of contraception.
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Site Reference ID/Investigator# 5870
Karachi, 74800
Site Reference ID/Investigator# 21441
Karachi
Site Reference ID/Investigator# 6130
Lahore
Site Reference ID/Investigator# 8535
Rawalpindi
About this study
Official title: A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)
Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Itopride HCI 50 mg, Itopride HCI 100 mg, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itopride HCI 50 mgDrug
Also called ABT-654, Itopride HCI, Ganaton
Variable dosing
Itopride HCI 100 mgDrug
Also called ABT-654, Itopride HCI, Ganaton
Variable dosing
PlaceboDrug
Variable dosing
| Study group | Role | What they receive |
|---|---|---|
| Itopride 50 mg | Active comparator | Not described Receives: Drug: Itopride HCI 50 mg |
| Itopride 100 mg | Active comparator | Not described Receives: Drug: Itopride HCI 100 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
Measured: 2 weeks and 4 weeks after the start of the treatment
Secondary outcomes (2)
Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).
Measured: 2 weeks and 4 weeks after the start of the treatment
Safety based on the laboratory tests before and at the end of the treatment.
Measured: 4 weeks during the treatment period and 4 weeks following post- therapy period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027260
- Sponsor's protocol ID
- R10-257
- Status last verified
- Jun 2013
- First submitted
- 4 Dec 2009
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)
- ClinicalTrials.gov ID
- NCT01027260
- Acronym / sponsor ID
- R10-257
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Itopride 50 mg | Active comparator | Drug: Itopride HCI 50 mg |
| Itopride 100 mg | Active comparator | Drug: Itopride HCI 100 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female patient fulfilling the Rome III criteria for IBS-C
- Signed informed consent at screening visit
Key exclusion criteria (12 listed)
- Patients having significant diarrhea at least 25% of the time during the past 3 months
- Patients having alarm symptoms or signs
- Chronic diarrhea
- History of gastrointestinal haemorrhage, mechanical obstruction or perforation
- Patient with clinically relevant ECG abnormalities (prolonged QT interval)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itopride HCI 50 mgAlso: ABT-654, Itopride HCI, GanatonVariable dosing | Drug | Itopride 50 mg |
| Itopride HCI 100 mgAlso: ABT-654, Itopride HCI, GanatonVariable dosing | Drug | Itopride 100 mg |
| PlaceboVariable dosing | Drug | Placebo |
Primary outcome
Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
Time frame: 2 weeks and 4 weeks after the start of the treatment
2 secondary outcomes
Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).
Time frame: 2 weeks and 4 weeks after the start of the treatment
Safety based on the laboratory tests before and at the end of the treatment.
Time frame: 4 weeks during the treatment period and 4 weeks following post- therapy period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itopride HCI 50 mg and Itopride HCI 100 mg in people with Irritable Bowel Syndrome, run by Abbott at 4 sites in Pakistan.
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 2 inclusion and 12 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 18 Jun 2013. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms" (time frame: 2 weeks and 4 weeks after the start of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2013.