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NCT01665157
A Randomized, Single-blinded, Comparative Study to Evaluate the Efficacy and the Acceptability of Low-residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
NA trial testing Enimaclin® in Dietary Modification in 180 participants. Completed in 1 June 2012.
1 June 2012
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Enrollment | 180 |
| Start date | 1 November 2011 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 June 2012 |
| Sites | 4 locations across Taiwan |
Drugs / interventions tested
- Enimaclin®
- Self-controlled diet
- 2L PEG-ELS — full drug profile →
- low volume 1.5L PEG-ELS — full drug profile →
Conditions studied
- Dietary Modification — all drugs for Dietary Modification →
Sponsor
National Taiwan University Hospital
Who can join
Adults 20 to 75, any sex, with Dietary Modification. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale
Time frame: 1 day
Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean co -
Overall Cleansing Level at Colonoscopy by Aronchick Scale
Time frame: 1 day
The overall proportion of participants scored as Excellent or Good by Aronchick scale. Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present -
Total Volume of Purgatives That Ingested
Time frame: 1 day
The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy -
Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)
Time frame: 1 day
Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of "right segment" preparation failure, defined as segmental score as "3 poor" or "4 inadequate", was presented.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01665157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other National Taiwan University Hospital trials
Trials by the same sponsor.
- NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
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- NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
- NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
- NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01665157 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 18 February 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01665157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing