A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy

Summary

The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.

Timeline

Start

2017-02-20

Primary completion

2017-09-15

Completion

2017-10-12

Outcome

Met primary endpoint

paper SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders versus 81.5% (369/453) responders [difference (95% confidence interval): 6.3% (1.8, 10.9)]}. PMID 31205487 ↗

paper According to the prespecified hierarchical testing, after meeting the primary and key secondary objectives, SPMC oral solution was tested for superiority to P/MC powder for the primary endpoint (p = 0.0067). PMID 31205487 ↗

Publications

• Mankaney GN, Ando M, Dahdal DN, Burke CA. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial. Ther Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021.
• Hookey L, Bertiger G, Johnson KL 2nd, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 10.1177/1756284820910050. eCollection 2020.
• Hookey L, Bertiger G, Johnson KL, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 10.1177/1756284820902878. eCollection 2020.
• Hookey L, Bertiger G, Lee Johnson K 2nd, Ayala J, Seifu Y, Brogadir SP. Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial. Ther Adv Gastroenterol. 2019 May 19;12:1756284819851510. doi: 10.1177/1756284819851510. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid	Unknown	—	Oral

Indications

No indication recorded.