A Phase 4 interventional study of Phosphate Enema (Kleen® Enema) in Irritable Bowel Syndrome, sponsored by Nabiqasim Industries (Pvt) Ltd. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Nabiqasim Industries (Pvt) Ltd · Phase 4, Interventional, and Diagnostic
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
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
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
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Nabiqasim Industries (Pvt) Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Phosphate Enema (Kleen® Enema)
120ml (single bottle) administered via rectal route before 30min of sigmoidoscopy .
Also known as: Brand name is Kleen® Enema
Excellent Preparation for Sigmoidoscopy (efficacy)
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.
Time frame: 30 minutes after administration of the Enema
The record gives a start of Mar 2015, a primary completion of Jun 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nabiqasim Industries (Pvt) Ltd