Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation

NCT00645801 | Completed Phase 4 Results

• 1 other identifier: 07-024L
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see the colon better during the colonoscopy to identify abnormal growths such as polyps or colon cancer. Colonoscopy is considered the best way to screen for colon cancer screening because you can visualize the colon directly and remove or biopsy abnormal growths. The limiting step in the procedure is the quality of the colon preparation prior to the procedure. Many patients do not tolerate large volumes of liquid used to prepare the colon. The purpose of the study is to improve the quality of the prep by adding a pill laxative medication before starting the large volume laxative to better see the colon. The other aim of the study is to try to reduce the amount of of liquid laxative the patient has to drink by giving a pill laxative before starting the liquid laxative.

Conditions

Colonoscopy

Keywords

Routine screening colonoscopy; Colonoscopy Preparation; Amitiza; GoLYTELY; Pegylated Electrolytes; Preparation Solution; Colonoscopy Solution

Outcome Measures

Primary Outcomes (1)

• Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group

  Endoscopists evaluated the quality of the colonoscopy preparation based on Ottawa bowel preparation scale. . The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. Before using the scale for this trial, the endoscopists participated in a calibration exercise that involved 20 patients to ensure that they concurred on their interpretation of the scale.

  within 12 hours of completing bowel prep

Secondary Outcomes (2)

• Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group

  done at the time of colonoscopy

• Change in Volume of PEG From Beginning of Bowel Prep to That at Completion of the Colonoscopy Preparation in the Two Groups

  amount of PEG at start of the study and that measured when the patient presented for their procedure.

Study Arms (2)

Ingested 4 tablets of lubiprostone in divided doses + 1 gallon of polyethylene glycol

ACTIVE COMPARATOR

First dose of lubiprostone 24 micrograms or placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were on a clear liquid diet on the day before the procedure and were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. All study patients were educated and instructed to observe for clear stool, which was defined as "watery consistency without any solid fecal material or dark liquid stools." Patients were instructed to return the unused PEG solution on the day of colonoscopy. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution.

Drug: lubiprostone (Amitiza)

Ingested 4 tablets of placebo in divided doses + 1 gallon of polyethylene glycol

PLACEBO COMPARATOR

First dose of look alike placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were on a clear liquid diet on the day before the procedure and were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. All study patients were educated and instructed to observe for clear stool, which was defined as "watery consistency without any solid fecal material or dark liquid stools." Patients were instructed to return the unused PEG solution on the day of colonoscopy. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution.

Drug: Placebo

Interventions

lubiprostone (Amitiza) DRUG

24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total

Also known as: Amitiza

Ingested 4 tablets of lubiprostone in divided doses + 1 gallon of polyethylene glycol

Placebo DRUG

Amitiza Placebo

Also known as: Look alike placebo Amitiza

Ingested 4 tablets of placebo in divided doses + 1 gallon of polyethylene glycol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years old
• Subject is in good health
• Subject is undergoing a screening, surveillance or diagnostic colonoscopy
• Subject has a spontaneous bowel movement at least every 48 hours

You may not qualify if:

• Subject has renal insufficiency demonstrated by serum creatinine \> 1.4mg/dL
• Subject has Type 1 diabetes
• Subject has past or present diagnosis of Congestive Heart Failure
• Subject has past or present diagnosis of inflammatory bowel disease
• Subject had previous colon resection
• Subject has a preexisting electrolyte abnormality
• Subject has more than 3 spontaneous bowel movements daily

Sponsors & Collaborators

• Henry Ford Health System: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (3)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Henry Ford Health System

West Bloomfield, Michigan, 48322, United States

Location

Related Publications (18)

• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.

  PMID: 15758907 BACKGROUND

• Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.

  PMID: 12838225 BACKGROUND

• Afridi SA, Barthel JS, King PD, Pineda JJ, Marshall JB. Prospective, randomized trial comparing a new sodium phosphate-bisacodyl regimen with conventional PEG-ES lavage for outpatient colonoscopy preparation. Gastrointest Endosc. 1995 May;41(5):485-9. doi: 10.1016/s0016-5107(05)80008-2.

  PMID: 7615228 BACKGROUND

• Johanson JF, Ueno R. Lubiprostone, a locally acting chloride channel activator, in adult patients with chronic constipation: a double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety. Aliment Pharmacol Ther. 2007 Jun 1;25(11):1351-61. doi: 10.1111/j.1365-2036.2007.03320.x.

  PMID: 17509103 BACKGROUND

• Camilleri M, Bharucha AE, Ueno R, Burton D, Thomforde GM, Baxter K, McKinzie S, Zinsmeister AR. Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers. Am J Physiol Gastrointest Liver Physiol. 2006 May;290(5):G942-7. doi: 10.1152/ajpgi.00264.2005.

  PMID: 16603730 BACKGROUND

• Stengel JZ, Jones DP. Single-dose lubiprostone along with split-dose PEG solution without dietary restrictions for bowel cleansing prior to colonoscopy: a randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2008 Sep;103(9):2224-30. doi: 10.1111/j.1572-0241.2008.02053.x. Epub 2008 Aug 5.

  PMID: 18684185 BACKGROUND

• Grigg E, Schubert MC, Hall J, Rahhal F, Raina D, Sridhar S, Chamberlain SM. Lubiprostone used with polyethylene glycol in diabetic patients enhances colonoscopy preparation quality. World J Gastrointest Endosc. 2010 Jul 16;2(7):263-7. doi: 10.4253/wjge.v2.i7.263.

  PMID: 21160617 BACKGROUND

• Park JS, Sohn CI, Hwang SJ, Choi HS, Park JH, Kim HJ, Park DI, Cho YK, Jeon WK, Kim BI. Quality and effect of single dose versus split dose of polyethylene glycol bowel preparation for early-morning colonoscopy. Endoscopy. 2007 Jul;39(7):616-9. doi: 10.1055/s-2007-966434.

  PMID: 17611916 BACKGROUND

• Aoun E, Abdul-Baki H, Azar C, Mourad F, Barada K, Berro Z, Tarchichi M, Sharara AI. A randomized single-blind trial of split-dose PEG-electrolyte solution without dietary restriction compared with whole dose PEG-electrolyte solution with dietary restriction for colonoscopy preparation. Gastrointest Endosc. 2005 Aug;62(2):213-8. doi: 10.1016/s0016-5107(05)00371-8.

  PMID: 16046981 BACKGROUND

• 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: 20561621 BACKGROUND

• Unger RZ, Amstutz SP, Seo DH, Huffman M, Rex DK. Willingness to undergo split-dose bowel preparation for colonoscopy and compliance with split-dose instructions. Dig Dis Sci. 2010 Jul;55(7):2030-4. doi: 10.1007/s10620-009-1092-x. Epub 2010 Jan 16.

  PMID: 20082216 BACKGROUND

• American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.

  PMID: 21307770 BACKGROUND

• Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.

  PMID: 20485282 BACKGROUND

• Abdul-Baki H, Hashash JG, Elhajj II, Azar C, El Zahabi L, Mourad FH, Barada KA, Sharara AI. A randomized, controlled, double-blind trial of the adjunct use of tegaserod in whole-dose or split-dose polyethylene glycol electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2008 Aug;68(2):294-300; quiz 334, 336. doi: 10.1016/j.gie.2008.01.044. Epub 2008 Jun 3.

  PMID: 18511049 BACKGROUND

• 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: 16482236 BACKGROUND

• Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x.

  PMID: 11280539 BACKGROUND

• 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: 19251013 BACKGROUND

• Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.

  PMID: 15044882 BACKGROUND

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Director of Gastrointestinal Research
• Organization: retired

anngimd@icloud.com

Study Officials

• Ann L Silverman, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding was done to ensure minimum bias. The clinicians attending to the patients were not involved in the randomization process, and all were blinded to the identity of the drug received as the placebo was identical to the active drug in packaging, appearance, and schedule of administration. Separate individuals generated the allocation sequence, enrolled participants, and assigned participants to their groups. The blind was maintained until all decisions regarding data evaluability were made. Only the research assistant who assigned participants to their treatment groups was permitted access to the randomization list, which was maintained in a locked filing cabinet during the trial. The patients were blinded to their medication status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)