Non-erosive Reflux DiseasePhase 2/3NCT01269788
Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial
A Phase 2/3 study testing Fluoxetine and Omeprazole in people with Non-erosive Reflux Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the adult population in North America. Up to 70% of GERD patients have non-erosive reflux disease (NERD), a term used to describe symptoms suggestive of GERD in patients with no endoscopic evidence of erosive esophagitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-erosive Reflux Disease
- What is being tested?
- Fluoxetine and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteIran
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age above 18 and below 60 years old
- experiencing heartburn during last 6 months before inclusion
- experiencing heartburn during at least 4 of 7 days before inclusion
- presence of normal mucosa in upper gastrointestinal(GI) endoscopy which has been documented during 7 days before inclusion provided that the patient has not administered any PPI during last 30 days before inclusion
Who cannot join
- inability to undergone upper GI endoscopy or PH monitoring
- presence of barret's esophagus or erosive esophagitis in upper GI endoscopy
- presence of active peptic ulcer disease or any disease which affects the absorption of drugs such as inflammatory bowel disease
- past history of esophageal or gastric surgery
- esophageal stricture which needs dilation
- administration of proton pomp inhibitors during 30 days before inclusion to the study
Show all 13Show fewer
- administration of H2 blockers, anticholinergics, sucralfate and pro-kinetics during the assessments for eligibility and also during the study
- long time administration of non-steroidal anti-inflammatory drugs (NSAIDs)
- administration of neuroleptic or antidepressant drugs during 30 days before inclusion to the study
- known allergy to PPIs or SSRIs
- presence of significant systemic disease such as scleroderma , diabet mellitus , peripheral and autonomic neuropathies and ...
- pregnancy for females
- presence of known psychiatric disorder such as depression , panic disorder or drug addiction according to the DSM-IV criteria
Trial locations and contacts
1 site in 1 country.
Iran1 site
Gasterointestinal endoscopy ward, Amir Alam hospital, Tehran university of medical sciences
Tehran, Tehran Province
About this study
Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the adult population in North America. Up to 70% of GERD patients have non-erosive reflux disease (NERD), a term used to describe symptoms suggestive of GERD in patients with no endoscopic evidence of erosive esophagitis. NERD represents a heterogeneous group of patients whom are sub classified according to 24 hours-PH monitoring results and also symptom-acid association analysis(Symptom Index,SI).
Treatment of NERD can be a challenge for clinicians. According to the many studies , the pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as the most frequently used drug, in NERD patients is lower than for erosive esophagitis patients. It is also shown that acid exposure is much lower in NERD patients than those with erosive esophagitis and NERD patients are less likely to exhibit a strong association between heartburn symptoms and acid reflux events than patients with erosive oesophagitis.
Read more
Furthermore, beside the high economic burden, there are concerns about the adverse effects of long time administration of PPIs.
Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs. One of the most acceptable theories is that patients with anxiety or depression and psychological problems are at an increased risk of developing reflux symptoms. On the other hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI), and other antidepressants have been shown to improve symptoms in patients with functional gastrointestinal disorders like non cardiac chest pain.
According to the above-mentioned tips, the investigators hypothesize that antidepressants like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD patients.
The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo for treatment of NERD patients and its subgroups who all experience reflux symptoms and have normal endoscopic findings.
- Conditions
- Non-erosive Reflux Disease
- Being tested
- Fluoxetine, Omeprazole, placebo
- Keywords
- non-erosive reflux disease, heartburn, functional, Antidepressive Agents, Second-Generation, Proton Pump Inhibitors
- Medical subject headings
- Non-Erosive Reflux Disease, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
20 mg , oral , daily 30 mins before breakfast, for 6 weeks
OmeprazoleDrug
20 mg , oral , daily 30 mins before breakfast, for 6 weeks
placeboDrug
oral , daily 30 mins before breakfast, for 6 weeks
OmeprazoleDrug
20 mg , oral , daily 30 mins before breakfast, for 6 weeks
FluoxetineDrug
20 mg , oral , daily 30 mins before breakfast, for 6 weeks
placeboDrug
oral , daily 30 mins before breakfast, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| pH positive-omeprazole | Active comparator | Not described Receives: Drug: Omeprazole |
| pH positive-placebo | Placebo comparator | Not described Receives: Drug: placebo |
| pH positive-fluoxetine | Active comparator | Not described Receives: Drug: Fluoxetine |
| pH negative-omeprazole | Active comparator | Not described Receives: Drug: Omeprazole |
| pH negative-fluoxetine | Active comparator | Not described Receives: Drug: Fluoxetine |
| pH negative-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.
investigator-reported symptom severity
symptom severity at beginning and 6 weeks after the study ,assessed by the standard questionnaire
Measured: 6 weeks
Secondary outcomes (2)
patient-reported symptom severity
symptom severity reported by the patient in daily diary
Measured: 6 weeks
heartburn-free days
percentage of 24-h heartburn-free days (days with neither daytime nor nighttime heartburn) during treatment assessed by daily diary
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Non-erosive Reflux DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seyed Amir Mirbagheri, MD, Study chair, Department of Internal Medicine, Faculty of medicine, Tehran university of medical sciencesMohammad Reza Ostovaneh, MD,MPH, Principal investigator, Tehran University of Medical SciencesArash Etemadi, MD, PhD, Principal investigator, Tehran University of Medical SciencesYasin Farrokhi Khajeh Pasha, MD, MPH, Principal investigator, Tehran University of Medical SciencesBehtash Saeidi, MD, Principal investigator, Tehran University of Medical SciencesKaveh Hajifathalian, MD, Principal investigator, Tehran University of Medical SciencesAkbar Fotouhi, MD, PhD, Principal investigator, Tehran University of Medical SciencesSeyed Mahmoud Eshagh hosseini, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269788
- Sponsor's protocol ID
- 89-02-30-10638
- Status last verified
- Mar 2012
- First submitted
- 21 Dec 2010
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Heidelbaugh JJ, Goldberg KL, Inadomi JM. Overutilization of proton pump inhibitors: a review of cost-effectiveness and risk [corrected]. Am J Gastroenterol. 2009 Mar;104 Suppl 2:S27-32. doi: 10.1038/ajg.2009.49.
PubMed 19262544Martinez SD, Malagon IB, Garewal HS, Cui H, Fass R. Non-erosive reflux disease (NERD)--acid reflux and symptom patterns. Aliment Pharmacol Ther. 2003 Feb 15;17(4):537-45. doi: 10.1046/j.1365-2036.2003.01423.x.
PubMed 12622762Raghunath AS, O'Morain C, McLoughlin RC. Review article: the long-term use of proton-pump inhibitors. Aliment Pharmacol Ther. 2005 Aug;22 Suppl 1:55-63. doi: 10.1111/j.1365-2036.2005.02611.x.
PubMed 16042660Dean BB, Gano AD Jr, Knight K, Ofman JJ, Fass R. Effectiveness of proton pump inhibitors in nonerosive reflux disease. Clin Gastroenterol Hepatol. 2004 Aug;2(8):656-64. doi: 10.1016/s1542-3565(04)00288-5.
PubMed 15290657Bradley LA, Richter JE, Pulliam TJ, Haile JM, Scarinci IC, Schan CA, Dalton CB, Salley AN. The relationship between stress and symptoms of gastroesophageal reflux: the influence of psychological factors. Am J Gastroenterol. 1993 Jan;88(1):11-9.
PubMed 8420248DeVault KR. Review article: the role of acid suppression in patients with non-erosive reflux disease or functional heartburn. Aliment Pharmacol Ther. 2006 Mar;23 Suppl 1:33-9. doi: 10.1111/j.1365-2036.2006.02798.x.
PubMed 16483268Venes DJ. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 Sep 29;331(13):882; author reply 882-3. No abstract available.
PubMed 8078547Handa M, Mine K, Yamamoto H, Hayashi H, Tsuchida O, Kanazawa F, Kubo C. Antidepressant treatment of patients with diffuse esophageal spasm: a psychosomatic approach. J Clin Gastroenterol. 1999 Apr;28(3):228-32. doi: 10.1097/00004836-199904000-00008.
PubMed 10192608Varia I, Logue E, O'connor C, Newby K, Wagner HR, Davenport C, Rathey K, Krishnan KR. Randomized trial of sertraline in patients with unexplained chest pain of noncardiac origin. Am Heart J. 2000 Sep;140(3):367-72. doi: 10.1067/mhj.2000.108514.
PubMed 10966532Broekaert D, Fischler B, Sifrim D, Janssens J, Tack J. Influence of citalopram, a selective serotonin reuptake inhibitor, on oesophageal hypersensitivity: a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2006 Feb 1;23(3):365-70. doi: 10.1111/j.1365-2036.2006.02772.x.
PubMed 16422995Rentz AM, Kahrilas P, Stanghellini V, Tack J, Talley NJ, de la Loge C, Trudeau E, Dubois D, Revicki DA. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res. 2004 Dec;13(10):1737-49. doi: 10.1007/s11136-004-9567-x.
PubMed 15651544Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.
PubMed 19392864Ostovaneh MR, Saeidi B, Hajifathalian K, Farrokhi-Khajeh-Pasha Y, Fotouhi A, Mirbagheri SS, Emami H, Barzin G, Mirbagheri SA. Comparing omeprazole with fluoxetine for treatment of patients with heartburn and normal endoscopy who failed once daily proton pump inhibitors: double-blind placebo-controlled trial. Neurogastroenterol Motil. 2014 May;26(5):670-8. doi: 10.1111/nmo.12313. Epub 2014 Feb 7.
PubMed 24533896
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01269788
- Acronym / sponsor ID
- 89-02-30-10638
- Conditions
- Non-erosive Reflux Disease
- Keywords
- non-erosive reflux disease, heartburn, functional, Antidepressive Agents, Second-Generation, Proton Pump Inhibitors
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Jan 2011 (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.
Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the adult population in North America. Up to 70% of GERD patients have non-erosive reflux disease (NERD), a term used to describe symptoms suggestive of GERD in patients with no endoscopic evidence of erosive esophagitis. NERD represents a heterogeneous group of patients whom are sub classified according to 24 hours-PH monitoring results and also symptom-acid association analysis(Symptom Index,SI).
Treatment of NERD can be a challenge for clinicians. According to the many studies , the pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as the most frequently used drug, in NERD patients is lower than for erosive esophagitis patients. It is also shown that acid exposure is much lower in NERD patients than those with erosive esophagitis and NERD patients are less likely to exhibit a strong association between heartburn symptoms and acid reflux events than patients with erosive oesophagitis.
Furthermore, beside the high economic burden, there are concerns about the adverse effects of long time administration of PPIs.
Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs. One of the most acceptable theories is that patients with anxiety or depression and psychological problems are at an increased risk of developing reflux symptoms. On the other hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI), and other antidepressants have been shown to improve symptoms in patients with functional gastrointestinal disorders like non cardiac chest pain.
According to the above-mentioned tips, the investigators hypothesize that antidepressants like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD patients.
The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo for treatment of NERD patients and its subgroups who all experience reflux symptoms and have normal endoscopic findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| pH positive-omeprazole | Active comparator | Drug: Omeprazole |
| pH positive-placebo | Placebo comparator | Drug: placebo |
| pH positive-fluoxetine | Active comparator | Drug: Fluoxetine |
| pH negative-omeprazole | Active comparator | Drug: Omeprazole |
| pH negative-fluoxetine | Active comparator | Drug: Fluoxetine |
| pH negative-placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age above 18 and below 60 years old
- experiencing heartburn during last 6 months before inclusion
- experiencing heartburn during at least 4 of 7 days before inclusion
- presence of normal mucosa in upper gastrointestinal(GI) endoscopy which has been documented during 7 days before inclusion provided that the patient has not administered any PPI during last 30 days before inclusion
Key exclusion criteria (13 listed)
- inability to undergone upper GI endoscopy or PH monitoring
- presence of barret's esophagus or erosive esophagitis in upper GI endoscopy
- presence of active peptic ulcer disease or any disease which affects the absorption of drugs such as inflammatory bowel disease
- past history of esophageal or gastric surgery
- esophageal stricture which needs dilation
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 |
|---|---|---|
| Fluoxetine20 mg , oral , daily 30 mins before breakfast, for 6 weeks | Drug | pH positive-fluoxetine |
| Omeprazole20 mg , oral , daily 30 mins before breakfast, for 6 weeks | Drug | pH positive-omeprazole |
| placebooral , daily 30 mins before breakfast, for 6 weeks | Drug | pH positive-placebo |
| Omeprazole20 mg , oral , daily 30 mins before breakfast, for 6 weeks | Drug | pH negative-omeprazole |
| Fluoxetine20 mg , oral , daily 30 mins before breakfast, for 6 weeks | Drug | pH negative-fluoxetine |
| placebooral , daily 30 mins before breakfast, for 6 weeks | Drug | pH negative-placebo |
Primary outcome
investigator-reported symptom severity
Time frame: 6 weeks
symptom severity at beginning and 6 weeks after the study ,assessed by the standard questionnaire
2 secondary outcomes
patient-reported symptom severity
Time frame: 6 weeks
heartburn-free days
Time frame: 6 weeks
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 6 Mar 2012.
- Background: PubMed 19262544Heidelbaugh JJ, Goldberg KL, Inadomi JM. Overutilization of proton pump inhibitors: a review of cost-effectiveness and risk [corrected]. Am J Gastroenterol. 2009 Mar;104 Suppl 2:S27-32. doi: 10.1038/ajg.2009.49.
- Background: PubMed 12622762Martinez SD, Malagon IB, Garewal HS, Cui H, Fass R. Non-erosive reflux disease (NERD)--acid reflux and symptom patterns. Aliment Pharmacol Ther. 2003 Feb 15;17(4):537-45. doi: 10.1046/j.1365-2036.2003.01423.x.
- Background: PubMed 16042660Raghunath AS, O'Morain C, McLoughlin RC. Review article: the long-term use of proton-pump inhibitors. Aliment Pharmacol Ther. 2005 Aug;22 Suppl 1:55-63. doi: 10.1111/j.1365-2036.2005.02611.x.
- Background: PubMed 15290657Dean BB, Gano AD Jr, Knight K, Ofman JJ, Fass R. Effectiveness of proton pump inhibitors in nonerosive reflux disease. Clin Gastroenterol Hepatol. 2004 Aug;2(8):656-64. doi: 10.1016/s1542-3565(04)00288-5.
- Background: PubMed 8420248Bradley LA, Richter JE, Pulliam TJ, Haile JM, Scarinci IC, Schan CA, Dalton CB, Salley AN. The relationship between stress and symptoms of gastroesophageal reflux: the influence of psychological factors. Am J Gastroenterol. 1993 Jan;88(1):11-9.
- Background: PubMed 16483268DeVault KR. Review article: the role of acid suppression in patients with non-erosive reflux disease or functional heartburn. Aliment Pharmacol Ther. 2006 Mar;23 Suppl 1:33-9. doi: 10.1111/j.1365-2036.2006.02798.x.
- Background: PubMed 8078547Venes DJ. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 Sep 29;331(13):882; author reply 882-3. No abstract available.
- Background: PubMed 10192608Handa M, Mine K, Yamamoto H, Hayashi H, Tsuchida O, Kanazawa F, Kubo C. Antidepressant treatment of patients with diffuse esophageal spasm: a psychosomatic approach. J Clin Gastroenterol. 1999 Apr;28(3):228-32. doi: 10.1097/00004836-199904000-00008.
- Background: PubMed 10966532Varia I, Logue E, O'connor C, Newby K, Wagner HR, Davenport C, Rathey K, Krishnan KR. Randomized trial of sertraline in patients with unexplained chest pain of noncardiac origin. Am Heart J. 2000 Sep;140(3):367-72. doi: 10.1067/mhj.2000.108514.
- Background: PubMed 16422995Broekaert D, Fischler B, Sifrim D, Janssens J, Tack J. Influence of citalopram, a selective serotonin reuptake inhibitor, on oesophageal hypersensitivity: a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2006 Feb 1;23(3):365-70. doi: 10.1111/j.1365-2036.2006.02772.x.
- Background: PubMed 15651544Rentz AM, Kahrilas P, Stanghellini V, Tack J, Talley NJ, de la Loge C, Trudeau E, Dubois D, Revicki DA. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res. 2004 Dec;13(10):1737-49. doi: 10.1007/s11136-004-9567-x.
- Background: PubMed 19392864Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.
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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.
Seyed Amir Mirbagheri, MD study chair
Department of Internal Medicine, Faculty of medicine, Tehran university of medical sciences
Mohammad Reza Ostovaneh, MD,MPH principal investigator
Tehran University of Medical Sciences
Arash Etemadi, MD, PhD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fluoxetine and Omeprazole in people with Non-erosive Reflux Disease, run by Tehran 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 4 inclusion and 13 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 6 Mar 2012. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
investigator-reported symptom severity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269788, which also lists 13 linked publications.
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 6 Mar 2012.