NCT01929590

Brief Summary

the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

August 2, 2013

Last Update Submit

August 21, 2013

Conditions

Bowel Preparation for Colonoscopy

Keywords

ColonoscopyPreparationPolypPolyethylene glycol

Outcome Measures

Primary Outcomes (1)

  • satisfactory bowel preparation

    The aim of this study was to test the quality of bowel preparation and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments. The quality of colonic preparation was assessed by the Boston bowel preparation scale.Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

    at the moment of colonoscopy

Secondary Outcomes (1)

  • tolerability with bowel preparation

    just before to start the colonoscopy and before any sedative be administered

Study Arms (3)

PEG-3350 group 3

ACTIVE COMPARATOR

group 3: low-volume 2 L PEG-3350 solution (same day of the procedure 06:00-08:00 am).

Drug: PEG-3350 group 3

PEG-3350 group 1

ACTIVE COMPARATOR

group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h)

Drug: PEG-3350 group 1

PEG-3350 group 2

EXPERIMENTAL

group 2: split-dose (PEG-3350 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)

Drug: PEG-3350 group 2

Interventions

PEG-3350 group 2DRUG

split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)

Also known as: Nulytely
PEG-3350 group 2
PEG-3350 group 1DRUG

PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h

Also known as: Nulytely
PEG-3350 group 1
PEG-3350 group 3DRUG

low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)

Also known as: Nulytely
PEG-3350 group 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In-hospital patients with an indication for colonoscopy

You may not qualify if:

  • patients under 18 years of age
  • the presence of a severe illness (cardiac, renal, or metabolic)
  • major psychiatric illness
  • known allergies to PEG-3350
  • refusal to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

Location

Related Publications (16)

  • Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.

    PMID: 23335011BACKGROUND

  • Corporaal S, Kleibeuker JH, Koornstra JJ. Low-volume PEG plus ascorbic acid versus high-volume PEG as bowel preparation for colonoscopy. Scand J Gastroenterol. 2010 Nov;45(11):1380-6. doi: 10.3109/00365521003734158. Epub 2010 Jul 5.

    PMID: 20602568BACKGROUND

  • Adams WJ, Meagher AP, Lubowski DZ, King DW. Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation. Dis Colon Rectum. 1994 Mar;37(3):229-33; discussion 233-4. doi: 10.1007/BF02048160.

    PMID: 8137669BACKGROUND

  • Jansen SV, Goedhard JG, Winkens B, van Deursen CT. Preparation before colonoscopy: a randomized controlled trial comparing different regimes. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):897-902. doi: 10.1097/MEG.0b013e32834a3444.

    PMID: 21900786BACKGROUND

  • Marmo R, Rotondano G, Riccio G, Marone A, Bianco MA, Stroppa I, Caruso A, Pandolfo N, Sansone S, Gregorio E, D'Alvano G, Procaccio N, Capo P, Marmo C, Cipolletta L. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions. Gastrointest Endosc. 2010 Aug;72(2):313-20. doi: 10.1016/j.gie.2010.02.048. Epub 2010 Jun 19.

    PMID: 20561621BACKGROUND

  • Pontone S, Angelini R, Standoli M, Patrizi G, Culasso F, Pontone P, Redler A. Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy. World J Gastroenterol. 2011 Nov 14;17(42):4689-95. doi: 10.3748/wjg.v17.i42.4689.

    PMID: 22180711BACKGROUND

  • Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Runzi M, Schneider T, Kachel G, Gruger J, Kollinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008 Apr;103(4):883-93. doi: 10.1111/j.1572-0241.2007.01708.x. Epub 2008 Jan 11.

    PMID: 18190651BACKGROUND

  • Abut E, Guveli H, Yasar B, Bolukbas C, Bolukbas FF, Ince AT, Kendir T, Dalay AR, Kurdas OO. Administration of olive oil followed by a low volume of polyethylene glycol-electrolyte lavage solution improves patient satisfaction with right-side colonic cleansing over administration of the conventional volume of polyethylene glycol-electrolyte lavage solution for colonoscopy preparation. Gastrointest Endosc. 2009 Sep;70(3):515-21. doi: 10.1016/j.gie.2009.01.002. Epub 2009 Jun 24.

    PMID: 19555936BACKGROUND

  • Enestvedt BK, Brian Fennerty M, Zaman A, Eisen GM. MiraLAX vs. Golytely: is there a significant difference in the adenoma detection rate? Aliment Pharmacol Ther. 2011 Oct;34(7):775-82. doi: 10.1111/j.1365-2036.2011.04795.x. Epub 2011 Aug 17.

    PMID: 21848798BACKGROUND

  • Haapamaki MM, Lindstrom M, Sandzen B. Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol. Surg Endosc. 2011 Mar;25(3):897-901. doi: 10.1007/s00464-010-1293-6. Epub 2010 Sep 2.

    PMID: 20812020BACKGROUND

  • DiPalma JA, McGowan J, Cleveland MV. Clinical trial: an efficacy evaluation of reduced bisacodyl given as part of a polyethylene glycol electrolyte solution preparation prior to colonoscopy. Aliment Pharmacol Ther. 2007 Oct 15;26(8):1113-9. doi: 10.1111/j.1365-2036.2007.03459.x.

    PMID: 17894653BACKGROUND

  • Hookey LC, Depew WT, Vanner SJ. Combined low volume polyethylene glycol solution plus stimulant laxatives versus standard volume polyethylene glycol solution: a prospective, randomized study of colon cleansing before colonoscopy. Can J Gastroenterol. 2006 Feb;20(2):101-5. doi: 10.1155/2006/621367.

    PMID: 16482236BACKGROUND

  • Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

    PMID: 19136102BACKGROUND

  • Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.

    PMID: 19251013BACKGROUND

  • Seo EH, Kim TO, Park MJ, Joo HR, Heo NY, Park J, Park SH, Yang SY, Moon YS. Optimal preparation-to-colonoscopy interval in split-dose PEG bowel preparation determines satisfactory bowel preparation quality: an observational prospective study. Gastrointest Endosc. 2012 Mar;75(3):583-90. doi: 10.1016/j.gie.2011.09.029. Epub 2011 Dec 15.

    PMID: 22177570BACKGROUND

  • Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.

    PMID: 20883845BACKGROUND

MeSH Terms

Conditions

Polyps

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Felix Téllez-Ávila, Ph.D.

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 28, 2013

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

ME(1)