Last reviewed · How we verify
NCT01650870
A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
Phase 2 trial testing Crystalline Lactulose in Colonoscopy in 40 participants. Completed in 1 September 2012.
1 September 2012
Quick facts
| Lead sponsor | Benaroya Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 July 2012 |
| Primary completion | 1 September 2012 |
| Estimated completion | 1 September 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Crystalline Lactulose — full drug profile →
Conditions studied
- Colonoscopy — all drugs for Colonoscopy →
Sponsor
Benaroya Research Institute
Who can join
18 and older, any sex, with Colonoscopy. 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.
-
Cleanliness of the Colon During Colonoscopy
Time frame: Day of the procedure
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
Sponsor's own description
The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).
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 NCT01650870
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colonoscopy
Currently open trials in the same condition.
- NCT07353853 — Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease · NA · recruiting
- NCT07335705 — Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients · recruiting
- NCT06763705 — Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy · Phase 4 · recruiting
- NCT07171853 — The Carbon Footprint Study of Colonoscopy · recruiting
- NCT07355777 — Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation · NA · recruiting
Other Benaroya Research Institute trials
Trials by the same sponsor.
- NCT07377929 — Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterj · recruiting
- NCT06265376 — Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy? · NA · completed
- NCT05281614 — Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D · EARLY_PHASE1 · completed
- NCT05847413 — Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D · EARLY_PHASE1 · completed
- NCT04197570 — Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial · Phase 3 · completed
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 NCT01650870 (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 Benaroya Research Institute
- Last refreshed: 7 August 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/NCT01650870.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing