Irritable Bowel SyndromePhase 4PRITONNCT02573844
Pain Relief In Irritable Bowel Syndrome
A Phase 4 study testing Proklama in people with Irritable Bowel Syndrome, run by Geophyt S.r.l.s. at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Proklama
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Jun 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 y.o.
- clinical diagnosis of IBS following Rome III symptom- based criteria:
- abdominal pain or discomfort recurring for at least 3 days a month in the previous 3 months, associated with 2 of the following characteristics at least: improved with evacuation; onset associated with variation of stool frequency; onset associated with changes in stool consistency
- onset of symptomatology at least 6 months preceding diagnosis
- additional criterion: mean severity of abdominal pain higher than 3 in the 11-points NRS
- For patients over 50 y.o. or with positive familiarity for colorectal cancer: normal colonoscopy performed within 5 years from the beginning of the screening's period and after symptomatology's onset
Show all 16Show fewer
- For patients over 65 y.o. : absence of ischemic / microscopic colitis, or other organic gastrointestinal disorders, as highlighted through colonoscopy with biopsy performed within 6 months from the beginning of the screening's period
- For fertile and sexually active women: use of effective contraception with failure rate of less than 1% for one year during the trial period and 30 days after its end.
- Oral contraceptive are admitted as long as formulation didn't undergo changes during the 6 months preceeding the trial.
- Physical examination is negative during the period of screening
- Absence of significant alterations in 12- lead ECG during the period of screening.
- Normal haematochemical parameters during the period of screening
- Compliant patients towards procedures provided for the study, especially the use of daily diary
- Patients with mental integrity, able to express an informed before any procedure related to protocol, compliant toward clinical examinations provided for the protocol.
- Patients willing to avoid loperamide and laxatives use during the 3 days preceding run in and during the whole run in's period ( to be verified before randomization)
- Patients that during both the 2 run in's weeks reported an average daily intensity of abdominal pain for every week >3 on 0-10 (NRS)
Who cannot join
- Male gender
- Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS according to the Rome III criteria
- Patient has had surgery that meets any of the following criteria:
- colonic or major abdominal surgery, i.e. bariatric surgery and stomach, small/ large bowel or large vessel abdominal surgery ( except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery).
- Patient has any elective major surgery planned or expected at any time during the study.
- Patient has a history of inflammation bowel diseases, complicated diverticulosis ( i.e. diverticulitis), ischaemic colitis, microscopic colitis.
Show all 41Show fewer
- Patient has a history of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation ( e.g., aortoiliac disease).
- Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
- Patient has an active biliary duct disease of a history of Sphincter of Oddi dysfunction.
- Patient has a history of gluten enteropathy.
- Patient has a history of lactose intolerance as assessed by response to diet.
- Patient has a current or previous diagnosis of neoplasia ( except non-GI) neoplasia in complete remission < or = 5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
- Patient has a history of ectopic endometriosis.
- Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
- Patient has a history of human immunodeficiency virus infection.
- Patient has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure ( NYHA class > 2), or transient ischemic attack in the previous 6 months.
- Patient has uncontrolled hypertension, defined as systolic blood pressure <180 mmHg or a diastolic blood pressure < 100 mmHg.
- Patient has insulin- dependent diabetes mellitus.
- Patient has a major pshychiatric or neurological disorders.
- Patient has an unstable medical condition which may compromise the efficacy and safety assessments as required in the study and/or require change in concomitant medication.
- Patient has a history of abnormal thyroid function. Patient is candidate for the study if thyroid hormone replacement therapy is stable from at least 2 months.
- Patient has evidence of clinically hepatic disease as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times rthe upper limit of normal or total bilirubin >3 mg/dl (>51.3 mmoL/L), with the exception of Gilbert's syndrome or albumin < 2.8 g/dL during the Screening period.
- Patient has a sever renal insufficiency ( Glomerular Filtration Rate [GFR] <30 mL/min/ 1.73 m^2 calculated by the Cockcroft. Gault formula adjusted for the body surface area [BSA]) during the Screening period
- Patient has evidence of anemia as confirmed by hemoglobin < 9 g/dL during the Screening period.
- Relevant changes in dietary habits, lifestyle or exercise regimen should be maintained for the duration of the study.
- Use of prohibited concurrent medication within the previous month, namely:
- Antibiotics ( 4 months in the case of rifaximin);
- 5- HT3 antagonists alosetron.
- Use of prohibited concurrent medication in the previous 7 days namely:
- Antimuscarinic drugs;
- Drug enhancing GI motility such as prokinetic agents and other stimulants of GI contractility drugs, laxatives, or anti- diarrhoeal agents ( except for loperamide, please refer to inclusion criterion No.12);
- Analgesic drugs ( opioids or non- steroidal anti- inflammatory drugs). NOTE: short term use of paracetamol is allowed for max 2 consecutive days;
- Fibre products and herbal preparations;
- Antidepressants. NOTE: the use of a single antidepressant is only allowed when the drug type and its dose regimen have not been changed in the previous 6 months;
- Benzodiazepines. NOTE: the use of a single benzodiazepine is only allowed when it is administered as sleep- inducer and the drug type and its dose regimen have not been changed in the previous 6 months.
- Pregnancy or breastfeeding.
- Hypersensitivity to the drug excipients.
- Patient is not able to understand or collaborate throughout the study.
- Patient is unable to swallow solid, oral dosage forms whole with the aid of liquid ( patients may not chew, divide, dissolve, or crush the study drug).
- Partecipation in other clinical studies in the previous 4 weeks or the patient is currently enrolled in a clinical study with another investigational drug.
- Patient has any condition that, in the opinion of the Investigator, would compromise the well- being of the patient or the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Proklama on Patients' Symptoms With Irritable Bowel Syndrome: Clinical Trial, Double- Blind, Crossover, Controlled Study vs. Placebo
The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.
Read the detailed description
This is a phase IV, double- blind, randomized, placebo controlled, monocentric study.
Males and women over 18 y.o. with Irritable bowel syndrome (IBS) diagnosed applying Rome III criteria will be enrolled consecutively.
The study consist of 4 periods:
- A screening's period of 2 weeks starting from visit 1, useful to screen potentially eligible patients performing diagnostic investigations necessary to confirm diagnosis.
- A run- in's period, starting from visit 2 and lasting 2 weeks will represent a baseline without specific treatments in order to characterize the severity of symptomatology and evaluate patients' compliance relative to daily diaries
- A 2 weeks- treatment's period ( active/ placebo) starting from visit 3. The 1st day of the period of treatment, eligible patients will be randomized following a 1:1 ratio to receive Proklama ( 1 sachet/ day) or placebo. Treatments will be administered daily during the whole 2 weeks- treatment's period.
- A wash out's period lasting 2 weeks starting from visit 4, to be performed the day after the end of the 2 weeks- treatment's period.
- A 2 weeks- treatment's period ( placebo/ active) starting from visit 5, to be performed the last day of wash out's period. During this visit patients will receive the second treatment, following a crossover design.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Proklama, Placebo
- Keywords
- irritable bowel syndrome, abdominal pain, rome III criteria, abdominal distension, consistency of stools, stool frequency, meteorism, flatulence, abdominal discomfort, proklama, probiotics, alga klamath, aphanizomenon flos-aquae, prebiotics, colitis ulcerosa
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain, Flatulence, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProklamaDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A: Proklama ( 1 sachet/ day) | Active comparator | 15 patients belonging to group A will receive drug A (Proklama: 1 sachet/ day). The treatment will be administred starting from visit 3 for a 2 weeks- treatment's period.
After a 2 weeks wash out's period, patients belonging to group A, starting from visit 5, will receive drug B ( Placebo: 1 sachet/day). Receives: Drug: Proklama |
| B: Placebo ( 1 sachet/ day) | Placebo comparator | 15 patients belonging to group B will receive drug B (Placebo: 1 sachet/ day). The treatment will be administred starting from visit 3 for a 2 weeks- treatment's period.
After a 2 weeks wash out's period, patients belonging to group B, starting from visit 5, will receive drug A ( Proklama: 1 sachet/day). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recorded pain in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of the most severe pain occurred in the previous 24 hours.
Pain severity is scored 0-10 ( 0= absent; 10= pain as bad as can be).
Measured: 24 h
Secondary outcomes (15)
Recorded abdominal distension in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of abdominal distension occurred in the previous 24 hours.
Abdominal distension is scored 0-10 ( 0= absent; 10= abdominal distension as bad as can be).
Measured: 24 h
Recorded abdominal discomfort in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of abdominal discomfort occurred in the previous 24 hours.
Abdominal discomfort is scored 0-10 ( 0= absent; 10= abdominal discomfort as bad as can be).
Measured: 24 h
Recorded abdominal meteorism in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of abdominal meteorism occurred in the previous 24 hours.
Abdominal meteorism is scored 0-10 ( 0= absent; 10= abdominal meteorism as bad as can be).
Measured: 24 h
Recorded flatulence in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of flatulence occurred in the previous 24 hours. Flatulence is scored 0-10 ( 0= absent; 10= flatulence as bad as can be).
Measured: 24 h
Recorded borborygmi in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of borgorygms occurred in the previous 24 hours. Borborygmi is scored 0-10 ( 0= absent; 10= borborygmi as bad as can be).
Measured: 24 h
Recorded nausea in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of nausea occurred in the previous 24 hours. Nausea is scored 0-10 ( 0= absent; 10= nausea as bad as can be).
Measured: 24 h
Recorded belching in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of belching occurred in the previous 24 hours. Belching is scored 0-10 ( 0= absent; 10= belching as bad as can be).
Measured: 24 h
Recorded asthenia in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of asthenia occurred in the previous 24 hours. Asthenia is scored 0-10 ( 0= absent; 10= asthenia as bad as can be).
Measured: 24 h
Recorded headache in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of headache occurred in the previous 24 hours. Headache is scored 0-10 ( 0= absent; 10= headache as bad as can be).
Measured: 24 h
Recorded "empty- head" feeling in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of "empty- head" feeling occurred in the previous 24 hours.
"Empty- head" feeling is scored 0-10 ( 0= absent; 10= "empty- head" feeling as bad as can be).
Measured: 24 h
Recorded attention deficity in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of attention deficity occurred in the previous 24 hours.
Attention deficity is scored 0-10 ( 0= absent; 10= attention deficity as bad as can be).
Measured: 24 h
Recorded vomiting feeling in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of vomiting occurred in the previous 24 hours. Vomiting feeling is scored 0-10 ( 0= absent; 10= vomiting as bad as can be).
Measured: 24 h
Recorded heartburn in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of heartburn occurred in the previous 24 hours. Heartburn is scored 0-10 ( 0= absent; 10= heartburn as bad as can be).
Measured: 24 h
Number of evacuations recorded in a diary
Self reported record of number of evacuations in the previous 24 h.
Measured: 24 h
Recorded stool consistency in a diary using a 7- point Bristol Stool Form Scale
Self reported evaluation of stool consistency occurred in the previous 24 hours.
Stool consistency is scored 1- 7 ( 1= constipation; 7=diarrhoea)
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2017
- Study completionJun 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geophyt S.r.l.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573844
- Sponsor's protocol ID
- Geophyt
- Acronym
- PRITON
- Status last verified
- Aug 2021
- First submitted
- 8 Oct 2015
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proklama on Patients' Symptoms With Irritable Bowel Syndrome: Clinical Trial, Double- Blind, Crossover, Controlled Study vs. Placebo
- ClinicalTrials.gov ID
- NCT02573844
- Acronym / sponsor ID
- PRITON / Geophyt
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, abdominal pain, rome III criteria, abdominal distension, consistency of stools, stool frequency, meteorism, flatulence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Geophyt S.r.l.s.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 12 Oct 2015 (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 whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.
Detailed description
This is a phase IV, double- blind, randomized, placebo controlled, monocentric study.
Males and women over 18 y.o. with Irritable bowel syndrome (IBS) diagnosed applying Rome III criteria will be enrolled consecutively.
The study consist of 4 periods:
- A screening's period of 2 weeks starting from visit 1, useful to screen potentially eligible patients performing diagnostic investigations necessary to confirm diagnosis.
- A run- in's period, starting from visit 2 and lasting 2 weeks will represent a baseline without specific treatments in order to characterize the severity of symptomatology and evaluate patients' compliance relative to daily diaries
- A 2 weeks- treatment's period ( active/ placebo) starting from visit 3. The 1st day of the period of treatment, eligible patients will be randomized following a 1:1 ratio to receive Proklama ( 1 sachet/ day) or placebo. Treatments will be administered daily during the whole 2 weeks- treatment's period.
- A wash out's period lasting 2 weeks starting from visit 4, to be performed the day after the end of the 2 weeks- treatment's period.
- A 2 weeks- treatment's period ( placebo/ active) starting from visit 5, to be performed the last day of wash out's period. During this visit patients will receive the second treatment, following a crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Proklama ( 1 sachet/ day) | Active comparator | Drug: Proklama15 patients belonging to group A will receive drug A (Proklama: 1 sachet/ day). The treatment will be administred starting from visit 3 for a 2 weeks- treatment's period. After a 2 weeks wash out's period, patients belonging to group A, starting from visit 5, will receive drug B ( Placebo: 1 sachet/day). |
| B: Placebo ( 1 sachet/ day) | Placebo comparator | Drug: Placebo15 patients belonging to group B will receive drug B (Placebo: 1 sachet/ day). The treatment will be administred starting from visit 3 for a 2 weeks- treatment's period. After a 2 weeks wash out's period, patients belonging to group B, starting from visit 5, will receive drug A ( Proklama: 1 sachet/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- patients over 18 y.o.
- clinical diagnosis of IBS following Rome III symptom- based criteria:
- For patients over 50 y.o. or with positive familiarity for colorectal cancer: normal colonoscopy performed within 5 years from the beginning of the screening's period and after symptomatology's onset
- For patients over 65 y.o. : absence of ischemic / microscopic colitis, or other organic gastrointestinal disorders, as highlighted through colonoscopy with biopsy performed within 6 months from the beginning of the screening's period
- For fertile and sexually active women: use of effective contraception with failure rate of less than 1% for one year during the trial period and 30 days after its end.
Key exclusion criteria (41 listed)
- Male gender
- Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS according to the Rome III criteria
- Patient has had surgery that meets any of the following criteria:
- Patient has any elective major surgery planned or expected at any time during the study.
- Patient has a history of inflammation bowel diseases, complicated diverticulosis ( i.e. diverticulitis), ischaemic colitis, microscopic colitis.
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 |
|---|---|---|
| Proklama | Drug | A: Proklama ( 1 sachet/ day) |
| Placebo | Drug | B: Placebo ( 1 sachet/ day) |
Primary outcome
Recorded pain in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Self reported evaluation of the most severe pain occurred in the previous 24 hours. Pain severity is scored 0-10 ( 0= absent; 10= pain as bad as can be).
15 secondary outcomes
Recorded abdominal distension in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded abdominal discomfort in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded abdominal meteorism in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded flatulence in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded borborygmi in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded nausea in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded belching in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded asthenia in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded headache in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded "empty- head" feeling in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded attention deficity in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded vomiting feeling in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Recorded heartburn in a diary using a 11-points Numeric Rating Scale (NRS)
Time frame: 24 h
Number of evacuations recorded in a diary
Time frame: 24 h
Recorded stool consistency in a diary using a 7- point Bristol Stool Form Scale
Time frame: 24 h
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 9 Aug 2021.
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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 4 study testing Proklama in people with Irritable Bowel Syndrome, run by Geophyt S.r.l.s. at 1 site in Italy.
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 16 inclusion and 41 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 9 Aug 2021. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Recorded pain in a diary using a 11-points Numeric Rating Scale (NRS) (time frame: 24 h). 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 9 Aug 2021.