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. 2021 Oct 30;27(4):495–512. doi: 10.5056/jnm20210

Table 3.

Characteristics of Studies Comparing Novel Medications With Placebo

Study, country Comparison Design Eligible population Constipation criteria Intervention and duration Number of patients and mean age Primary outcome Results
Camilleri et al36 (2009), USA and Belgium Prucalopride vs Placebo Randomized, double-blind, Phase II, placebo-controlled, dose escalation study Elderly (> 65 yr) patients with constipation residing in a nursing facility Patients who had a history of constipation, having received treatment for constipation at any time during the 4 wk preceding entry into the study

  • A: Placebo

  • B: Prucalopride 0.5 mg qd

  • C: Prucalopride 1 mg qd

  • D: Prucalopride 2 mg qd

  • 4 wk

  • A: 18 (F 13)

  • B: 21 (F 18)

  • C: 24 (F 17)

  • D: 26 (F 17)

  • Mean age (range)

  • A: 85.4 (71-98) yr

  • B: 84.4 (75-98) yr

  • C: 82.6 (69-96) yr

  • D: 81.7 (65-94) yr

  1. Serious AEs

  2. Discontinuation d/t AEs

  3. QTc prolongation

  4. 24 hr Holter monitoring

 See Table 4
Müller-Lissner et al37 (2010), Germany and Belgium Prucalopride vs Placebo Multicenter, parallel-group, placebo-controlled Phase III trial Chronic constipation patients aged > 65 yr Two or fewer SCBMs per wk in the past 6 mo and one or more of the following for at least a quarter of the symptoms

  • A: Placebo

  • B: Prucalopride 1 mg qd

  • C: Prucalopride 2 mg qd

  • D: Prucalopride 4 mg qd

  • 4 wk

  • A: 72 (F 42)

  • B: 76 (F 58)

  • C: 75 (F 51)

  • D: 80 (F 60)

  • Mean age (range)

  • A: 76.0 (65-94) yr

  • B: 76.7 (65-92) yr

  • C: 75.6 (64-91) yr

  • D: 77.1 (65-95) yr

  1. Percentage of patients with ≥ 3 SCBM per wk

  2. SBMs/wk

  1. A 26.1% B 42.1% C 43.8% D 48.7%a

  2. A 4.2 → 5.1B 4.5 → 6.9a C 4.1 → 6.0 D 4.3 → 6.2a
Ueno et al38 (2006), USA Lubiprostone vs Placebo Pooled analysis of elderly subjects in 3 RCTs Chronic constipation patients aged ≥ 65 yr Rome II criteria for functional constipation

  • A: Lubiprostone 24 mg bid

  • B: Placebo

  • 4 wk

  • A: 26

  • B: 31

  • Mean age not specified

  1. Additional SBMs/wk compared with baseline

  2. Stool consistency and straining

  3. AEs

  1. A: 4.6-5.4B:1.3-2.3a

  2. Consistency and straining improved in lubiprostone group

  3. See Table 4
Nakajima et al39 (2019), Japan Elobixibat vs Placebo Post hoc analysis of randomized, placebo-controlled, phase 3 trials Patients with severe constipation ≤ 2 SBMs per wk and ≤ 3 Bristol Stool Form Scale score

  • A: elobixibat 10 mg qd

  • B: Placebo

  • 2 wk

  • A: 69 (elderly 6)

  • B: 63 (elderly 5)

 Additional SBMs/wk compared with placebo

  • Patients < 65: 4.5 (3.3-5.8)a

  • Patients ≥ 65: 6.0 (1.8-10.2)a
Menees et al40 (2020), USA Plecanatide vs Placebo Pooled analysis of 4 RCTs Chronic constipation and IBS-C Rome III criteria

  • A: Placebo

  • B: Plecanatide 3 mg qd

  • C: Plecanatide 6 mg qd

  • 12 wk

  • A: 162

  • B: 150

  • C: 138

  • Mean age of all patients 70.0 (4.3) yr

  1. AEs

  2. SCBMs/wk

  3. SBMs/wk

  1. See Table 4

  2. A 1.56 (0.26) B 2.63 (0.27)b C 2.07 (0.29)

  3. A 1.90 (0.32) B 3.27 (0.33)b C 2.61 (0.36)

aP < 0.05, bP < 0.01.

F, female; qd, once a day; bid, 2 times a day; AEs, adverse effects; QTc, corrected QT interval; SCBMs, spontaneous complete bowel movements; SBMs, spontaneous bowel movements; RCTs, randomized controlled trials; IBS-C, irritable bowel syndrome constipation type.