Irritable Bowel SyndromePhase 2NCT00139672
A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.
A Phase 2 study testing PD-217,014 in people with Irritable Bowel Syndrome, run by Pfizer.
Trial summary
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- PD-217,014
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Feb 2005
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females having Irritable bowel syndrome as defined by the Rome II criteria.
- Patients must have had normal examination of colon anatomy within the last 5 years
Who cannot join
- Patient with an organic gastrointestinal disease.
- Patients with poor renal function.
- Patients with severe constipation.
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Investigate The Effect Of Pd-217,014 In Patients With Irritable Bowel Syndrome (IBS)
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- PD-217,014
- 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.
PD-217,014Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks).
Secondary outcomes (1)
Assess the effect of PD-217,014 on the patient's global assessment of IBS symptoms, stool frequency & consistency and on abdominal bloating (change from baseline to week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionFeb 2005
- Study completionFeb 2005
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139672
- Sponsor's protocol ID
- A4451007
- Status last verified
- Jun 2008
- First submitted
- 29 Aug 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Investigate The Effect Of Pd-217,014 In Patients With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT00139672
- Acronym / sponsor ID
- A4451007
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 31 Aug 2005 (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.
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females having Irritable bowel syndrome as defined by the Rome II criteria.
- Patients must have had normal examination of colon anatomy within the last 5 years
Key exclusion criteria (3 listed)
- Patient with an organic gastrointestinal disease.
- Patients with poor renal function.
- Patients with severe constipation.
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 |
|---|---|---|
| PD-217,014 | Drug | – |
Primary outcome
Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks).
1 secondary outcome
Assess the effect of PD-217,014 on the patient's global assessment of IBS symptoms, stool frequency & consistency and on abdominal bloating (change from baseline to week 4).
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 17 Jun 2008.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-217,014 in people with Irritable Bowel Syndrome, run by Pfizer.
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 3 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 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks).. 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 17 Jun 2008.