Irritable Bowel SyndromePhase 2NCT00955994
Effect of Asimadoline, a Member of a New Medication Class, on Acute Attacks of Pain in Irritable Bowel Syndrome
A Phase 2 study testing asimadoline in people with Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is a placebo controlled study of the on demand treatment of pain experienced over a 4 week period in patients with irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- asimadoline
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant, non-breastfeeding females;
- 18-65 years old;
- Established diagnosis of IBS according to Rome II criteria.
- No alarm indicators on clinical assessment (weight loss of more than 7 kg, bleeding, unexplained recent rectal bleeding uninvestigated by colonoscopy or double contrast barium enema or flexible sigmoidoscopy for the passed 5 years).
- Females of childbearing potential who are sexually active must be using an acceptable method of contraception for a period of at least one month before the first dose of study medication, continuing through the duration of the study and for one month after the end of the study. Acceptable birth control methods are: surgical sterilization, oral or implanted contraceptive therapy, intrauterine devices and double barrier methods (diaphragm with spermicidal gel or foam or condoms with contraceptive gel or foam). Post-menopausal is defined as >12 months since last menses. Females who are abstinent may participate if they agree to use a double-barrier method of contraception throughout the study should they become sexually active. .
- Patients must provide written informed consent prior to inclusion in the study.
Who cannot join
- Patients with abdominal pain and discomfort scores less than 40 mm on a VAS or greater scores on less than 4 days out of 14 days during the run-in period (< 30 % of days during the run-in period).
- Patients with abdominal pain and discomfort scores more than 60 mm on a VAS on more than 10 days out of 14 days during the run-in period (> 70 % of days during the run-in period).
- Clinically significant abnormal laboratory values at the screening visit
- Structural or metabolic diseases/conditions that affect the gastrointestinal system. For screening the Bowel Disease Questionnaire 26 which follows in Appendix 1 will be used.
- Unable to withdraw medications during run-in period that:
- Alter GI transit including laxatives, antispasmodics, 5-HT 3 antagonists (e.g. alosetron, ondansetron), 5-HT 4 agonists (e.g. tegaserod), triptans (5-HT 1B or 1D agonists), magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, loperamide
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- Analgesic drugs including opiates, NSAID, COX 2 inhibitors
- Inhibiting CYP 3A4 and 2D6 including carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, systemic antifungal drugs (e.g. ketoconazole)
- Benzodiazepines NOTE: Low stable doses of antidepressants, thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
- History of positive stool cultures for pathogenic ova or parasites or enteric pathogens within the past 3 months, which has not been successfully eradicated.
- Female patients who are pregnant or breast-feeding.
- Clinical evidence (including physical exam, ECG, laboratory tests) and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. The Hospital Anxiety and Depression Scale (HADS)33 will be used to exclude patients with significant affective disorders, as well as to determine anxiety and depression scores at the start of the study.
- Patients known to be hypersensitive to Asimadoline or opioid agonists.
- Patients who have been previously exposed to Asimadoline.
- Patients who have participated in another clinical study within the past 30 days.
- Patients who are considered by the investigator to be alcoholics not in remission or known substance abusers.
- Previous gastric or intestinal surgery (except appendectomy, cholecystectomy or hysterectomy).
- Legal incapacity or limited legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Effect of On-demand Treatment With Asimadoline in Patients With Irritable Bowel Syndrome Over 4 Weeks
The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is a placebo controlled study of the on demand treatment of pain experienced over a 4 week period in patients with irritable bowel syndrome. Patients will record the severity of pain when they take the study medication and two hours later.
Read the detailed description
Background:
Asimadoline reduces visceral sensitivity in experimental animal models and has been tested for its effects on gastric sensorimotor function in healthy individuals. It reduces pain sensation in response to distensions that correspond to pressures frequently encountered in the human colon. However, the effects on improvement of pain and gastrointestinal symptoms in individuals with irritable bowel syndrome (IBS) are unclear.
Hypothesis:
The kappa opioid agonist, Asimadoline, reduces pain and discomfort and decreases gastrointestinal symptoms in participants with IBS.
Aim The aim is to compare the effects of Asimadoline (0.5 mg p.r.n, up to 1mg q.i.d.) and placebo on pain and discomfort and other gastrointestinal symptoms in patients with IBS.
Methods:
This is a phase IIB, single center, randomised, double-blind, placebo controlled study of the treatment of pain and discomfort associated with IBS in which study medication or placebo will be administered as required for the relief of these symptoms up to 2 tablets, 4 times per day. After a 2-week run-in period to characterize the nature, frequency and severity of pain to ensure eligibility for the study, participants will treat these pain episodes as the need arises but with strict recommendations on how to self-administer the medication (number, time interval etc?) over a period of 4 weeks. No other pain medications will be permitted during these first 6 weeks (2 weeks run-in, 4 weeks of randomized treatment). During the study, patients will collect daily data which will characterize their pain and other symptoms of IBS, and adequate relief of pain/discomfort. The participants will also keep track of their symptoms and any medications used during a two week observation period after the last dose of medication. A blood sample will be taken and DNA extracted to assess whether IBS patients have single nucleotide polymorphisms in the gene for the kappa receptor.
Anticipated Results and Future Directions:
We anticipate demonstrating that exacerbations of pain in IBS can be effectively reduced by intermittent treatment with the medication, asimadoline. This study will provide preliminary data that will then be used to estimate the sample size required for a phase III program of trials in several centers.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- asimadoline
- 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.
asimadolineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of abdominal pain 2 hours after treatment of pain
Average pain reduction within 2 hours after first dose each day ( pain intensity on VAS before and two hours after the first dose on each day with at least moderate pain)
The primary efficacy analysis includes all days with complete data sets for VAS before and two hours after intake of study medication and a before-treatment pain intensity of at least 30 mm on the VAS
For each of these days the pain reduction of the first dose will be calculated: PID (pain intensity difference) = Pain2h ? Pain0h
The average pain reduction on all these days will be calculated by: first, summing up all PID over the treatment period and second, dividing this result by the number of days with pain
Secondary outcomes (5)
Maximum pain during each day
Frequency of bowel movements (number)
Consistency of bowel movements (Bristol stool scale)
Ease of passage
Adequate relief of IBS pain and
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJan 2005
- Primary completionMar 2007
- Study completionMar 2007
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 Mayo ClinicThe 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955994
- Sponsor's protocol ID
- 2394-03
- Other IDs
- IND 67,533
- Status last verified
- Mar 2011
- First submitted
- 6 Aug 2009
- Last updated
- 23 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Effect of On-demand Treatment With Asimadoline in Patients With Irritable Bowel Syndrome Over 4 Weeks
- ClinicalTrials.gov ID
- NCT00955994
- Acronym / sponsor ID
- 2394-03
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Aug 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.
The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is a placebo controlled study of the on demand treatment of pain experienced over a 4 week period in patients with irritable bowel syndrome. Patients will record the severity of pain when they take the study medication and two hours later.
Detailed description
Background:
Asimadoline reduces visceral sensitivity in experimental animal models and has been tested for its effects on gastric sensorimotor function in healthy individuals. It reduces pain sensation in response to distensions that correspond to pressures frequently encountered in the human colon. However, the effects on improvement of pain and gastrointestinal symptoms in individuals with irritable bowel syndrome (IBS) are unclear.
Hypothesis:
The kappa opioid agonist, Asimadoline, reduces pain and discomfort and decreases gastrointestinal symptoms in participants with IBS.
Aim The aim is to compare the effects of Asimadoline (0.5 mg p.r.n, up to 1mg q.i.d.) and placebo on pain and discomfort and other gastrointestinal symptoms in patients with IBS.
Methods:
This is a phase IIB, single center, randomised, double-blind, placebo controlled study of the treatment of pain and discomfort associated with IBS in which study medication or placebo will be administered as required for the relief of these symptoms up to 2 tablets, 4 times per day. After a 2-week run-in period to characterize the nature, frequency and severity of pain to ensure eligibility for the study, participants will treat these pain episodes as the need arises but with strict recommendations on how to self-administer the medication (number, time interval etc?) over a period of 4 weeks. No other pain medications will be permitted during these first 6 weeks (2 weeks run-in, 4 weeks of randomized treatment). During the study, patients will collect daily data which will characterize their pain and other symptoms of IBS, and adequate relief of pain/discomfort. The participants will also keep track of their symptoms and any medications used during a two week observation period after the last dose of medication. A blood sample will be taken and DNA extracted to assess whether IBS patients have single nucleotide polymorphisms in the gene for the kappa receptor.
Anticipated Results and Future Directions:
We anticipate demonstrating that exacerbations of pain in IBS can be effectively reduced by intermittent treatment with the medication, asimadoline. This study will provide preliminary data that will then be used to estimate the sample size required for a phase III program of trials in several centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-pregnant, non-breastfeeding females;
- 18-65 years old;
- Established diagnosis of IBS according to Rome II criteria.
- No alarm indicators on clinical assessment (weight loss of more than 7 kg, bleeding, unexplained recent rectal bleeding uninvestigated by colonoscopy or double contrast barium enema or flexible sigmoidoscopy for the passed 5 years).
- Females of childbearing potential who are sexually active must be using an acceptable method of contraception for a period of at least one month before the first dose of study medication, continuing through the duration of the study and for one month after the end of the study. Acceptable birth control methods are: surgical sterilization, oral or implanted contraceptive therapy, intrauterine devices and double barrier methods (diaphragm with spermicidal gel or foam or condoms with contraceptive gel or foam). Post-menopausal is defined as >12 months since last menses. Females who are abstinent may participate if they agree to use a double-barrier method of contraception throughout the study should they become sexually active. .
Key exclusion criteria (18 listed)
- Patients with abdominal pain and discomfort scores less than 40 mm on a VAS or greater scores on less than 4 days out of 14 days during the run-in period (< 30 % of days during the run-in period).
- Patients with abdominal pain and discomfort scores more than 60 mm on a VAS on more than 10 days out of 14 days during the run-in period (> 70 % of days during the run-in period).
- Clinically significant abnormal laboratory values at the screening visit
- Structural or metabolic diseases/conditions that affect the gastrointestinal system. For screening the Bowel Disease Questionnaire 26 which follows in Appendix 1 will be used.
- Unable to withdraw medications during run-in period that:
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 |
|---|---|---|
| asimadoline | Drug | – |
Primary outcome
Severity of abdominal pain 2 hours after treatment of pain
Average pain reduction within 2 hours after first dose each day ( pain intensity on VAS before and two hours after the first dose on each day with at least moderate pain)
The primary efficacy analysis includes all days with complete data sets for VAS before and two hours after intake of study medication and a before-treatment pain intensity of at least 30 mm on the VAS
For each of these days the pain reduction of the first dose will be calculated: PID (pain intensity difference) = Pain2h ? Pain0h
The average pain reduction on all these days will be calculated by: first, summing up all PID over the treatment period and second, dividing this result by the number of days with pain
5 secondary outcomes
Maximum pain during each day
Frequency of bowel movements (number)
Consistency of bowel movements (Bristol stool scale)
Ease of passage
Adequate relief of IBS pain and
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 23 Mar 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing asimadoline in people with Irritable Bowel Syndrome, run by Mayo Clinic 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 6 inclusion and 18 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 23 Mar 2011. 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 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?
Severity of abdominal pain 2 hours after treatment of pain. The study lists 5 primary outcomes in all. 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 23 Mar 2011.