Irritable Bowel Syndrome (IBS)Phase 1NCT00316550
Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome
A Phase 1 study testing AV608 in people with Irritable Bowel Syndrome (IBS), run by Avera Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- AV608
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2007
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, 18 to 65 years of age, inclusive
- Current diagnosis of Irritable Bowel Syndrome (IBS)
- Subjects 50 years of age or older must have had a barium enema and flexible sigmoidoscopy or a colonoscopy and provide a record of this test
- Willing to participate in this study as evidenced by a signed, written informed consent form (ICF)
- If female and of child-bearing potential, willing to avoid pregnancy and practice adequate birth control from the time of study enrollment through at least 30 days after the final dose of study medication
- If female, negative pregnancy test results
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- Right handed
- Ambulatory outpatient
- Agrees to refrain from blood donation during the course of the study
- Written and oral fluency in the English language
Who cannot join
- Evidence of structural abnormality of the gastrointestinal tract or GI diseases/conditions
- Current evidence or diagnosis of peptic ulcer
- Endoscopic bowel evaluation with evidence of cancer, inflammatory bowel disease, or other structural disease
- History of abdominal surgery such as adhesion lysis or any gastrointestinal surgery
- History of gastroesophageal reflux disease not controlled by a stable dose of medication
- Any evidence of or treatment of malignancy within the previous 5 years
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- Clinical evidence of any disease that may interfere with participation in the study
- Existence of surgical or medical conditions which interfere with the absorption, distribution, metabolism and excretion of the study drug
- Symptoms of a significant clinical illness within the 2 weeks prior to Screening
- Type 1 diabetes mellitus, insulin-dependent Type 2 diabetes mellitus, and thyroid disorders or other endocrine disorders that are not well controlled by appropriate therapy
- A QTc interval of greater than or equal to 450 msec at Screening
- Presence of a psychotic disorder, bipolar disorder, alcohol or substance dependence (other than nicotine dependence) or eating disorder within the previous year according to DSM-IV-TR criteria
- Seizure disorder
- Subjects who have previously participated in a clinical trial for AV608 (previously known as NKP608 and CGP608)
- Positive drug test result at Screening
- Use of investigational drugs, products or devices within 30 days prior to Screening
- Planned use of certain drugs during the study that affect the central nervous system, gastrointestinal motility, autonomic activity or pain sensation
- Use of pimozide, terfenadine, astemizole, or cisapride during the study
- Presence of moderate or severe allergy
- Regular intake of more than 2 units of alcohol per day
- Pregnant or breast feeding
- Subjects with morbid obesity
- Subjects with metal implants or large tattoo
- Any clinically significant abnormalities on the Screening physical examination, ECG or laboratory tests
- Members of the investigative staff or their immediate family members
- Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol
- Regular use of more than 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Neurovisceral Sciences and Women's Health
Los Angeles, California, 90095
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study to Assess the Effects of AV608 on Central Processing of Visceral Stimuli in Subjects With Irritable Bowel Syndrome
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study to assess the effects of AV608 on brain processing of visceral stimuli and emotional visual cues in subjects with IBS. Female subjects between 18 and 65 years of age who meet diagnostic criteria for Irritable Bowel Syndrome will be eligible for the study.
Eligible subjects will complete a baseline fMRI imaging procedure that includes both emotional visual cues and visceral stimulation. All subjects who participate in the study will receive 3 weeks of treatment with AV608 and 3 weeks of treatment with placebo during the course of the study; the order of the two treatments for each subject will be randomly determined.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- AV608
- Keywords
- Irritable Bowel Syndrome (IBS)
- 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.
AV608Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the effect of AV608 on regional brain responses as measured by fMRI during conditioned and unconditioned visceral pain due to rectal distension.
Secondary outcomes (1)
The effect of AV608 on regional brain responses to emotional visceral cues as measured by fMRI and the visceral pain threshold during rectal distension will be evaluated as secondary efficacy endpoints.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2007
- Study completionSep 2007
Why it stopped: Animal Safety Data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Investigators
- Joao Siffert, MD, Study director, Avera Pharmaceuticals, Inc.Kirsten Tillisch, MD, Principal investigator, UCLA Center for Neurovisceral Sciences and Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316550
- Sponsor's protocol ID
- AV608-107
- Status last verified
- Feb 2008
- First submitted
- 19 Apr 2006
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study to Assess the Effects of AV608 on Central Processing of Visceral Stimuli in Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00316550
- Acronym / sponsor ID
- AV608-107
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable Bowel Syndrome (IBS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Animal Safety Data
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Avera PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Study start
- Apr 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Apr 2006 (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 assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study to assess the effects of AV608 on brain processing of visceral stimuli and emotional visual cues in subjects with IBS. Female subjects between 18 and 65 years of age who meet diagnostic criteria for Irritable Bowel Syndrome will be eligible for the study.
Eligible subjects will complete a baseline fMRI imaging procedure that includes both emotional visual cues and visceral stimulation. All subjects who participate in the study will receive 3 weeks of treatment with AV608 and 3 weeks of treatment with placebo during the course of the study; the order of the two treatments for each subject will be randomly determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female, 18 to 65 years of age, inclusive
- Current diagnosis of Irritable Bowel Syndrome (IBS)
- Subjects 50 years of age or older must have had a barium enema and flexible sigmoidoscopy or a colonoscopy and provide a record of this test
- Willing to participate in this study as evidenced by a signed, written informed consent form (ICF)
- If female and of child-bearing potential, willing to avoid pregnancy and practice adequate birth control from the time of study enrollment through at least 30 days after the final dose of study medication
Key exclusion criteria (27 listed)
- Evidence of structural abnormality of the gastrointestinal tract or GI diseases/conditions
- Current evidence or diagnosis of peptic ulcer
- Endoscopic bowel evaluation with evidence of cancer, inflammatory bowel disease, or other structural disease
- History of abdominal surgery such as adhesion lysis or any gastrointestinal surgery
- History of gastroesophageal reflux disease not controlled by a stable dose of medication
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 |
|---|---|---|
| AV608 | Drug | – |
Primary outcome
The primary efficacy endpoint is the effect of AV608 on regional brain responses as measured by fMRI during conditioned and unconditioned visceral pain due to rectal distension.
1 secondary outcome
The effect of AV608 on regional brain responses to emotional visceral cues as measured by fMRI and the visceral pain threshold during rectal distension will be evaluated as secondary efficacy endpoints.
Results and safety
The study was stopped early (reason given: Animal Safety Data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
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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.
Joao Siffert, MD study director
Avera Pharmaceuticals, Inc.
Kirsten Tillisch, MD principal investigator
UCLA Center for Neurovisceral Sciences and Women's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV608 in people with Irritable Bowel Syndrome (IBS), run by Avera Pharmaceuticals at 1 site in United States.
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 10 inclusion and 27 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: stopped early, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Animal Safety Data). Results are not available in the source record.
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?
The primary efficacy endpoint is the effect of AV608 on regional brain responses as measured by fMRI during conditioned and unconditioned visceral pain due to rectal distension.. 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 25 Feb 2008.