Irritable Bowel SyndromePhase 4NCT02386904
Safety and Therapeutic Efficacy of Phosphate Enema (Kleen Enema) in Patients Undergoing Sigmoidoscopy
A Phase 4 study testing Phosphate Enema (Kleen® Enema) in people with Irritable Bowel Syndrome, run by Nabiqasim Industries (Pvt) Ltd at 1 site in Pakistan.
Trial summary
The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Phosphate Enema (Kleen® Enema)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2015to Aug 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male/Female; aged 18-60 years.
- Out-patients admitted for day care sigmoidoscopy requiring left sided bowel preparation
- Able to understand the informed consent, answer the questions either independently or with someone helps
Who cannot join
- In-patients undergoing sigmoidoscopy or as emergency procedures.
- Immunosuppressed patients.
- Patients with electrolyte imbalance or disturbance, Hyperphosphatemia, Hypocalcemia, Hypokalemia, Hypernatremia, Metabolic acidosis.
- Patients having nausea, vomiting, diarrhea at the time of investigational drug administration.
- Patients administering the medications known to affect renal perfusion, function, or hydration(Renal failure or acute kidney injury)
- Patients taking diuretics or other medications within two days prior to the procedure which may alter electrolytes
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- Patients with known hypersensitivity to any ingredient of the study drug/phosphate.
- Patients requiring colostomy.
- Conditions causing decreased gastric motility, e.g.,Suspected intestinal obstruction,Paralytic ileus Anorectal stenosis, Imperforate anus, Congenital or acquired megacolon
- Undiagnosed gastrointestinal pathology, e.g. Symptoms of appendicitis, intestinal perforation or active inflammatory bowel disease, Undiagnosed rectal bleeding, Dehydration and generally in all cases where absorption capacity is increased or elimination capacity is decreased
- Patients with any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any Cardiovascular disease,History of asthma, glaucoma, or raised intraocular pressure.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Liver and GI diseases, DUHS
Karachi, Sindh, 74200
Zahid Azam, FCPS,MBBS, +92-21-99215754-7, zahid.azam@duhs.edu.pk
Hafeezullah Shaikh, FCPS, MBBS, +92-21-99215754-7, hafeezullah.shaikh@duhs.edu.pk
About this study
Official title: Prospective, Interventional, Single Arm Study in Outpatients Undergoing Sigmoidoscopy for Evaluation of Efficacy and Safety of Kleen Enema 120ml (Phosphate Enema)
The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy
Read the detailed description
Safety and therapeutic efficacy of Phosphate enema (Kleen Enema®) in patients undergoing sigmoidoscopy. Prospective, interventional, single arm study in patients undergoing day care sigmoidoscopy for evaluation of efficacy and safety of Kleen Enema®(120ml phosphate enema); manufactured by Nabiqasim Industries (Pvt) Ltd, Karachi, Pakistan.
Methods \&Material:
Study will be conducted in patients undergoing sigmoidoscopy in day care at Dow University of Health Sciences, Ojha campus, Karachi. Each subject will receive the single dose of investigational drug (phosphate enema 120ml). Objectives of the study
- To determine the efficacy of Kleen Enema® for bowel preparation in out-patients undergoing to sigmoidoscopy procedure.
- To evaluate the Safety of Kleen Enema® in outpatients requiring sigmoidoscopy.
Rationale of the Study:
This would be helpful to determine the efficacy and safety of investigational product in local population.
Study Condition :
The study will be conducted in outpatients admitted for day care sigmoidoscopy requiring left sided bowel preparation for procedure. Each subject will receive the single dose of investigational drug (phosphate enema 120ml). Patient will remain in fasting condition at least 6 hours before procedure and half an hour after recovery from sedation; after this patient can take normal diet.
Ethical Considerations:
The study will be conducted after the approval by an Institutional review board of Dow University of Health Sciences, Karachi and in accordance to declaration of Helsinki, International Conference of Harmonization - Good Clinical Practices and Pakistan Good Clinical Practices guidelines to protect the rights and safety of human subjects as participants in the study.
Duration of study :
Study duration for primary efficacy end point evaluation will be the time period till sigmoidoscopy procedure is completed and patient is discharged from day care. While patient will come again for follow-up visit. Whole study will be completed in five months, after Institutional Review Board approval.
Sample Size:
Investigational drug will be administered to 40 Patients.The data of at least 35 patients will be included for efficacy study. While all enrolled patients who receive a single dose of study product will be included for safety evaluation.
Screening procedure Out patients visiting gastroenterology Out Patient Department requiring sigmoidoscopy will undergo screening procedure. Medical examination, history, vital signs, electrolytes test (Ca, Phosphate, Sodium and potassium levels) and CBC test will be performed. However the normal procedure and conditions required for sigmoidoscopy will be followed.
Drug administration Method for rectal enema:
Study patients should lay on left side with both knees bent, arms at rest.Remove protective shield from the enema container. With steady pressure, gently insert enema comfort tip into anus with nozzle pointing towards navel. Squeeze bottle until nearly all liquid is expelled. Discontinue use if resistance is encountered. Forcing the enema can result in injury.Return enema to carton for disposal. Generally, 2 to 5 minutes are sufficient to obtain the desired effect maximum to 30 minutes. Study subject may have an urge to evacuate the bowel.
Confinement :
After sigmoidoscopy is completed, patients will be monitored in the recovery room of endoscopy suite till patients are out of sedative effect.Safety Assessment Health assessment, including vital signs, physical examination and clinical laboratory testing (electrolyte test and CBC) will be performed at baseline; before sigmoidoscopy and electrolyte will be repeated within 10-30 minutes after dosing. Patients will be monitored after drug administration to determine any adverse events. Patients are encouraged to report any unusual feeling or adverse event to endoscopy research staff or research assistant. Patients will be monitored for pruritus, dehydration, nausea,vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain and any other adverse
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Phosphate Enema (Kleen® Enema)
- 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.
Phosphate Enema (Kleen® Enema)Drug
Also called Brand name is Kleen® Enema
120ml (single bottle) administered via rectal route before 30min of sigmoidoscopy .
| Study group | Role | What they receive |
|---|---|---|
| Phosphate Enema | Experimental | Phosphate Enema consisting on Monobasic Sodium Phosphate (USP) 19.2 gm /120 ml and Dibasic Sodium Phosphate (USP) 7.2 gm/120 ml Dosage Form: Enema Frequency: One time; 30 minutes before Sigmoidoscopy Receives: Drug: Phosphate Enema (Kleen® Enema) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent Preparation for Sigmoidoscopy (efficacy)
- Small amounts of faecal material in scattered locations removable by suctioning and not preventing satisfactory visualisation of bowel mucosa; ii. Excellent preparation, no faecal material.
Measured: 30 minutes after administration of the Enema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nabiqasim Industries (Pvt) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dow University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Hafeezullah Shaikh, FCPS, MBBS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386904
- Sponsor's protocol ID
- • KLEE-EFF-002-01
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Interventional, Single Arm Study in Outpatients Undergoing Sigmoidoscopy for Evaluation of Efficacy and Safety of Kleen Enema 120ml (Phosphate Enema)
- ClinicalTrials.gov ID
- NCT02386904
- Acronym / sponsor ID
- • KLEE-EFF-002-01
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nabiqasim Industries (Pvt) LtdIndustry (pharma, biotech, devices)
- Collaborators
- Dow University of Health Sciences
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 12 Mar 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 the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy
Detailed description
Safety and therapeutic efficacy of Phosphate enema (Kleen Enema®) in patients undergoing sigmoidoscopy. Prospective, interventional, single arm study in patients undergoing day care sigmoidoscopy for evaluation of efficacy and safety of Kleen Enema®(120ml phosphate enema); manufactured by Nabiqasim Industries (Pvt) Ltd, Karachi, Pakistan.
Methods \&Material:
Study will be conducted in patients undergoing sigmoidoscopy in day care at Dow University of Health Sciences, Ojha campus, Karachi. Each subject will receive the single dose of investigational drug (phosphate enema 120ml). Objectives of the study
- To determine the efficacy of Kleen Enema® for bowel preparation in out-patients undergoing to sigmoidoscopy procedure.
- To evaluate the Safety of Kleen Enema® in outpatients requiring sigmoidoscopy.
Rationale of the Study:
This would be helpful to determine the efficacy and safety of investigational product in local population.
Study Condition :
The study will be conducted in outpatients admitted for day care sigmoidoscopy requiring left sided bowel preparation for procedure. Each subject will receive the single dose of investigational drug (phosphate enema 120ml). Patient will remain in fasting condition at least 6 hours before procedure and half an hour after recovery from sedation; after this patient can take normal diet.
Ethical Considerations:
The study will be conducted after the approval by an Institutional review board of Dow University of Health Sciences, Karachi and in accordance to declaration of Helsinki, International Conference of Harmonization - Good Clinical Practices and Pakistan Good Clinical Practices guidelines to protect the rights and safety of human subjects as participants in the study.
Duration of study :
Study duration for primary efficacy end point evaluation will be the time period till sigmoidoscopy procedure is completed and patient is discharged from day care. While patient will come again for follow-up visit. Whole study will be completed in five months, after Institutional Review Board approval.
Sample Size:
Investigational drug will be administered to 40 Patients.The data of at least 35 patients will be included for efficacy study. While all enrolled patients who receive a single dose of study product will be included for safety evaluation.
Screening procedure Out patients visiting gastroenterology Out Patient Department requiring sigmoidoscopy will undergo screening procedure. Medical examination, history, vital signs, electrolytes test (Ca, Phosphate, Sodium and potassium levels) and CBC test will be performed. However the normal procedure and conditions required for sigmoidoscopy will be followed.
Drug administration Method for rectal enema:
Study patients should lay on left side with both knees bent, arms at rest.Remove protective shield from the enema container. With steady pressure, gently insert enema comfort tip into anus with nozzle pointing towards navel. Squeeze bottle until nearly all liquid is expelled. Discontinue use if resistance is encountered. Forcing the enema can result in injury.Return enema to carton for disposal. Generally, 2 to 5 minutes are sufficient to obtain the desired effect maximum to 30 minutes. Study subject may have an urge to evacuate the bowel.
Confinement :
After sigmoidoscopy is completed, patients will be monitored in the recovery room of endoscopy suite till patients are out of sedative effect.Safety Assessment Health assessment, including vital signs, physical examination and clinical laboratory testing (electrolyte test and CBC) will be performed at baseline; before sigmoidoscopy and electrolyte will be repeated within 10-30 minutes after dosing. Patients will be monitored after drug administration to determine any adverse events. Patients are encouraged to report any unusual feeling or adverse event to endoscopy research staff or research assistant. Patients will be monitored for pruritus, dehydration, nausea,vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain and any other adverse
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phosphate Enema | Experimental | Drug: Phosphate Enema (Kleen® Enema)Phosphate Enema consisting on Monobasic Sodium Phosphate (USP) 19.2 gm /120 ml and Dibasic Sodium Phosphate (USP) 7.2 gm/120 ml Dosage Form: Enema Frequency: One time; 30 minutes before Sigmoidoscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male/Female; aged 18-60 years.
- Out-patients admitted for day care sigmoidoscopy requiring left sided bowel preparation
- Able to understand the informed consent, answer the questions either independently or with someone helps
Key exclusion criteria (11 listed)
- In-patients undergoing sigmoidoscopy or as emergency procedures.
- Immunosuppressed patients.
- Patients with electrolyte imbalance or disturbance, Hyperphosphatemia, Hypocalcemia, Hypokalemia, Hypernatremia, Metabolic acidosis.
- Patients having nausea, vomiting, diarrhea at the time of investigational drug administration.
- Patients administering the medications known to affect renal perfusion, function, or hydration(Renal failure or acute kidney injury)
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 |
|---|---|---|
| Phosphate Enema (Kleen® Enema)Also: Brand name is Kleen® Enema120ml (single bottle) administered via rectal route before 30min of sigmoidoscopy . | Drug | Phosphate Enema |
Primary outcome
Excellent Preparation for Sigmoidoscopy (efficacy)
Time frame: 30 minutes after administration of the Enema
i. Small amounts of faecal material in scattered locations removable by suctioning and not preventing satisfactory visualisation of bowel mucosa; ii. Excellent preparation, no faecal material.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
Hafeezullah Shaikh, FCPS, MBBS principal investigator
Dow University of Health Sciences
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 Phosphate Enema (Kleen® Enema) in people with Irritable Bowel Syndrome, run by Nabiqasim Industries (Pvt) Ltd at 1 site in Pakistan.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Mar 2015. 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 Pakistan. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tasneem Ahmad, B.Pharm,Ph.D (+92 314 2120868, dr.tasneem@phaps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent Preparation for Sigmoidoscopy (efficacy) (time frame: 30 minutes after administration of the Enema). 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 17 Mar 2015.