Irritable Bowel SyndromePhase 2NCT01268709
Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome
A Phase 2 study testing Doxepin and Nortriptyline in people with Irritable Bowel Syndrome, run by Qom University of Medical Sciences at 1 site in Iran.
Trial summary
The objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Doxepin and Nortriptyline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Presence of diarrhea predominant irritable bowel syndrome according to ROME criteria
Who cannot join
- Gastrointestinal bleeding
- More than 5% weight loss in the last 6 months
- Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients
Trial locations and contacts
1 site in 1 country.
Iran1 site
Gastrointestinal Research center,Beheshti Hospital
Qom, Qom Province, 1677859642
About this study
The objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Doxepin, Nortriptyline, 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.
DoxepinDrug
NortriptylineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| doxepin | Active comparator | Not described Receives: Drug: Doxepin |
| nortriptyline | Active comparator | Not described Receives: Drug: Nortriptyline |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Qom University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Young Researchers Club
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268709
- Sponsor's protocol ID
- YRC-1246
- Status last verified
- Dec 2010
- First submitted
- 30 Dec 2010
- Last updated
- 31 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01268709
- Acronym / sponsor ID
- YRC-1246
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Qom University of Medical SciencesUniversity, hospital or other
- Collaborators
- Young Researchers Club
- First posted
- 31 Dec 2010 (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 objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.
Study design
- Primary purpose
- Treatment
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| doxepin | Active comparator | Drug: Doxepin |
| nortriptyline | Active comparator | Drug: Nortriptyline |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of diarrhea predominant irritable bowel syndrome according to ROME criteria
Key exclusion criteria (3 listed)
- Gastrointestinal bleeding
- More than 5% weight loss in the last 6 months
- Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients
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 |
|---|---|---|
| Doxepin | Drug | doxepin |
| Nortriptyline | Drug | nortriptyline |
| placebo | Drug | placebo |
Primary outcome
Not reported in the source record.
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 31 Dec 2010.
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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 Doxepin and Nortriptyline in people with Irritable Bowel Syndrome, run by Qom University of Medical Sciences at 1 site in Iran.
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 1 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 31 Dec 2010. 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 Iran. 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.
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 31 Dec 2010.