Trial Outcomes & Findings for A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy (NCT NCT01926444)
NCT ID: NCT01926444
Last Updated: 2019-05-08
Results Overview
The Primary Outcomes Measure was the pain VAS 100-mm AUC (0mm = no pain; 100mm = worst pain), constructed from serial pain VAS measurements performed during colonoscopy. At least 8 pain VAS measurements were made, and the length of the colonoscope inserted (or removed on the way out) was recorded at every measurement. The X-axis of the VAS versus anatomical locations was defined accordingly: each VAS value corresponded to a relative length of inserted colonoscope (d/2Lc) of the X axis, where d was the actual length of the inserted colonoscope and 2Lc represented twice the total length of the colon examined (Lc). Before scope insertion the X value equaled zero. Once the caecum was reached, the X value was 0.5. Upon complete removal of the endoscope, the X value was 1. This allowed standardization of colonic length between study subjects. Visceral pain AUC (mm) was calculated from all serial measurements, where the length of inserted colonoscope determined the VAS measurement's location
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
308 participants
Primary outcome timeframe
Assessed at different anatomical locations: (1) before colonoscopy, (2) insertion of scope in anus, (3) at rectosigmoid flexure, (4) at splenic flexure, (5) at hepatic flexure, (6) at caecum, (7) at splenic flexure on way back, (8) after colonoscopy.
Results posted on
2019-05-08
Participant Flow
First patient enrolled: 25 JULY 2013; Last patient completed: 03 MARCH 2014
A total of N=37 subjects were screen failures and were not randomized (total randomized = 271/308). Of those randomized, N=268 subjects received at least one dose of study drug, and were included in the Safety Population.
Participant milestones
| Measure |
GIC-1001 Low Dose
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
52
|
57
|
103
|
|
Overall Study
COMPLETED
|
56
|
52
|
53
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
2
|
Reasons for withdrawal
| Measure |
GIC-1001 Low Dose
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Overall Study
Colonoscopy not performed
|
0
|
0
|
4
|
2
|
Baseline Characteristics
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
Baseline characteristics by cohort
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.35 years
STANDARD_DEVIATION 7.04 • n=5 Participants
|
54.68 years
STANDARD_DEVIATION 5.81 • n=7 Participants
|
53.74 years
STANDARD_DEVIATION 6.89 • n=5 Participants
|
54.32 years
STANDARD_DEVIATION 7.32 • n=4 Participants
|
54.28 years
STANDARD_DEVIATION 6.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed at different anatomical locations: (1) before colonoscopy, (2) insertion of scope in anus, (3) at rectosigmoid flexure, (4) at splenic flexure, (5) at hepatic flexure, (6) at caecum, (7) at splenic flexure on way back, (8) after colonoscopy.Population: Primary endpoint assessed in the FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262) and PP analysis sets (randomized patients in the FA population with ≥80% treatment compliance, who had at least 6/8 VAS ratings and no major protocol deviations; N=213)
The Primary Outcomes Measure was the pain VAS 100-mm AUC (0mm = no pain; 100mm = worst pain), constructed from serial pain VAS measurements performed during colonoscopy. At least 8 pain VAS measurements were made, and the length of the colonoscope inserted (or removed on the way out) was recorded at every measurement. The X-axis of the VAS versus anatomical locations was defined accordingly: each VAS value corresponded to a relative length of inserted colonoscope (d/2Lc) of the X axis, where d was the actual length of the inserted colonoscope and 2Lc represented twice the total length of the colon examined (Lc). Before scope insertion the X value equaled zero. Once the caecum was reached, the X value was 0.5. Upon complete removal of the endoscope, the X value was 1. This allowed standardization of colonic length between study subjects. Visceral pain AUC (mm) was calculated from all serial measurements, where the length of inserted colonoscope determined the VAS measurement's location
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)
AUC LOCF (standardized); FAS
|
25.5 mm
Standard Deviation 19.77
|
23.44 mm
Standard Deviation 18.7
|
27.73 mm
Standard Deviation 18.00
|
27.55 mm
Standard Deviation 20.00
|
|
Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)
AUC- censorsed (standardized); FAS
|
22.27 mm
Standard Deviation 16.31
|
18.93 mm
Standard Deviation 13.11
|
23.31 mm
Standard Deviation 16.12
|
22.22 mm
Standard Deviation 16.44
|
|
Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)
AUC- censorsed (standardized); PP
|
20.79 mm
Standard Deviation 16.56
|
17.6 mm
Standard Deviation 13.31
|
24.61 mm
Standard Deviation 17.18
|
22.03 mm
Standard Deviation 16.35
|
|
Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)
AUC LOCF (standardized); PP
|
20.96 mm
Standard Deviation 16.41
|
17.63 mm
Standard Deviation 13.29
|
24.8 mm
Standard Deviation 17.17
|
22.00 mm
Standard Deviation 16.28
|
SECONDARY outcome
Timeframe: From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.Population: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Time to Caecum is the time taken by the physician to reach the caecum with the colonoscope, from the insertion in the anus. Time to Caecum was measured during colonoscopy, for which total duration of colonoscopy ranged between a minimum of 5.00 and a maximum of 50.10 minutes.
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Time to Caecum
|
8.47 minutes
Standard Deviation 4.75
|
6.51 minutes
Standard Deviation 2.67
|
9.22 minutes
Standard Deviation 6.10
|
8.04 minutes
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: Number of patients during trial with a complete colonoscopy, where the scope has reached the caecum during the colonoscopy. Range of duration of colonoscopy 5.00- 50.10 minutes.Population: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Qualitative outcome: colonoscopy completion is defined as a procedure performed entirely, from initial anal insertion, reaching of caecum, and complete removal of the scope. Completion rate is then the number of patient (%) with a complete colonoscopy (up to the caecum) divided by the number of trial participants.
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Colonoscopy Completion Rate (%)
|
56 Participants
|
52 Participants
|
51 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Day 4 prior to colonoscopy.Population: Trimebutine and N-Desmethyl-Trimebutine plasma concentrations were assessed in all arms, with the exception of placebo
A pharmacokinetic (PK) analysis was carried out on the first 24 patients randomized, equally distributed between treatment groups; 18 patients were assigned to active treatment
Outcome measures
| Measure |
GIC-1001 Low Dose
n=6 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=6 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=6 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Safety-Plasma Concentrations of Trimebutine and N-Desmethyl-Trimebutine
Plasma Concentration- Trimebutine
|
5.17 ng/mL
Standard Deviation 1.96
|
8.80 ng/mL
Standard Deviation 3.55
|
16.22 ng/mL
Standard Deviation 7.32
|
—
|
|
Safety-Plasma Concentrations of Trimebutine and N-Desmethyl-Trimebutine
Plasma Concentration-N-Desmethyl-Trimebutine
|
174.5 ng/mL
Standard Deviation 130.1
|
440.98 ng/mL
Standard Deviation 546.53
|
389.18 ng/mL
Standard Deviation 166.42
|
—
|
SECONDARY outcome
Timeframe: From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.Population: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Defined as the time from endoscope insertion to complete removal of the endoscope; measured in minutes
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Total Examination Time (Colonoscopy)
|
15.82 minutes
Standard Deviation 7.06
|
13.05 minutes
Standard Deviation 6.22
|
15.52 minutes
Standard Deviation 8.08
|
14.61 minutes
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.Population: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Endoscopist's perception of the adequacy of analgesia, difficulty of insertion and withdrawal measured on a five-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Adequate Analgesia · Strongly Disagree
|
5 Participants
|
4 Participants
|
5 Participants
|
12 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Insertion · Strongly Agree
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Withdrawal · Agree
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Adequate Analgesia · Strongly Agree
|
20 Participants
|
18 Participants
|
16 Participants
|
33 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Adequate Analgesia · Agree
|
14 Participants
|
21 Participants
|
17 Participants
|
30 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Adequate Analgesia · Agree nor Disagree
|
8 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Adequate Analgesia · Disagree
|
9 Participants
|
6 Participants
|
11 Participants
|
16 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Insertion · Agree
|
7 Participants
|
6 Participants
|
7 Participants
|
24 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Insertion · Agree nor Disagree
|
6 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Insertion · Disagree
|
22 Participants
|
19 Participants
|
21 Participants
|
31 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Insertion · Strongly Disagree
|
18 Participants
|
20 Participants
|
18 Participants
|
31 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Withdrawal · Strongly Agree
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Withdrawal · Agree nor Disagree
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Withdrawal · Disagree
|
19 Participants
|
18 Participants
|
15 Participants
|
29 Participants
|
|
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Difficult Withdrawal · Strongly Disagree
|
37 Participants
|
32 Participants
|
36 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.Population: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Endoscopist's perception of the amount of colonic spasm on insertion and withdrawal measured on five-point Likert scale according to the following: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
|---|---|---|---|---|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm insertion · Present and very high (>5 spasms)
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm WIthdrawal · Present and high # (4-5 spasms)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm WIthdrawal · Present and very high (>5 spasms)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm insertion · Absent
|
33 Participants
|
33 Participants
|
33 Participants
|
59 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm insertion · Present and minimal # (1 spasm)
|
11 Participants
|
7 Participants
|
11 Participants
|
20 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm insertion · Present and moderate #(2-3 spasms)
|
8 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm insertion · Present and high # (4-5 spasms)
|
2 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
|
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm WIthdrawal · Absent
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41 Participants
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40 Participants
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45 Participants
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83 Participants
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Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm WIthdrawal · Present and minimal # (1 spasm)
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11 Participants
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8 Participants
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6 Participants
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14 Participants
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Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Colonic Spasm WIthdrawal · Present and moderate #(2-3 spasms)
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2 Participants
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4 Participants
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2 Participants
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3 Participants
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SECONDARY outcome
Timeframe: Post-colonoscopy- during subject recoveryPopulation: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Patients' willingness for repeat colonoscopy, was assessed with the Patient Willingness to Repeat Experience (P.W.R.E.) questionnaire (1 question), asking patients to rate their willingness to repeat the procedure according to a 5-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree. The P.W.R.E was administered after the colonoscopy during subject recovery.
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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Patient's Willingness to Repeat Experience
Strongly Agree
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23 Participants
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26 Participants
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15 Participants
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42 Participants
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Patient's Willingness to Repeat Experience
Agree
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16 Participants
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17 Participants
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18 Participants
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32 Participants
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Patient's Willingness to Repeat Experience
Strongly Disagree
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4 Participants
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2 Participants
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8 Participants
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8 Participants
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Patient's Willingness to Repeat Experience
Agree nor Disagree
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8 Participants
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2 Participants
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5 Participants
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11 Participants
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Patient's Willingness to Repeat Experience
Disagree
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5 Participants
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5 Participants
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5 Participants
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6 Participants
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Patient's Willingness to Repeat Experience
Missing
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0 Participants
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0 Participants
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2 Participants
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2 Participants
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SECONDARY outcome
Timeframe: Post-colonoscopy- during subject recoveryPopulation: FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)
Subject satisfaction and acceptability of the colonic analgesia modality offered by GIC-1001 was assessed with the Patient Global Impression of Abdominal Pain (P.G.I.A.P.) (1 question), asking patients to rate their pain during the procedure according to a 5-point Likert scale: Absent, Mild, Moderate, Severe, Intolerable. The P.G.I.A.P was administered after the colonoscopy during subject recovery.
Outcome measures
| Measure |
GIC-1001 Low Dose
n=56 Participants
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 Participants
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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GIC-1001 , High Dose
n=53 Participants
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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GIC-1001 Matching Placebo
n=101 Participants
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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|---|---|---|---|---|
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Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Absent
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6 Participants
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4 Participants
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3 Participants
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13 Participants
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Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Severe
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12 Participants
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7 Participants
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8 Participants
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21 Participants
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Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Intolerable
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0 Participants
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3 Participants
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3 Participants
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6 Participants
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Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Missing
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0 Participants
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0 Participants
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2 Participants
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2 Participants
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Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Mild
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21 Participants
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17 Participants
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15 Participants
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30 Participants
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Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Moderate
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17 Participants
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21 Participants
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22 Participants
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29 Participants
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Adverse Events
GIC-1001 Low Dose
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
GIC-1001 Mid-dose
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
GIC-1001 , High Dose
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
GIC-1001 Matching Placebo
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GIC-1001 Low Dose
n=56 participants at risk
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 Mid-dose
n=52 participants at risk
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
|
GIC-1001 , High Dose
n=57 participants at risk
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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GIC-1001 Matching Placebo
n=103 participants at risk
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
GIC-1001: GIC-1001 oral tablet, white-coated, to be taken with water
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|---|---|---|---|---|
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Gastrointestinal disorders
Diverticulum
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21.4%
12/56 • Number of events 68 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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19.2%
10/52 • Number of events 62 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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31.6%
18/57 • Number of events 65 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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21.4%
22/103 • Number of events 127 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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Gastrointestinal disorders
Abdominal pain lower
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5.4%
3/56 • Number of events 3 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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7.7%
4/52 • Number of events 5 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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8.8%
5/57 • Number of events 5 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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7.8%
8/103 • Number of events 9 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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Gastrointestinal disorders
Haemorrhoids
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25.0%
14/56 • Number of events 14 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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28.8%
15/52 • Number of events 15 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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26.3%
15/57 • Number of events 15 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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34.0%
35/103 • Number of events 35 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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Gastrointestinal disorders
Nausea
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10.7%
6/56 • Number of events 6 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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9.6%
5/52 • Number of events 5 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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8.8%
5/57 • Number of events 5 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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14.6%
15/103 • Number of events 17 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
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Gastrointestinal disorders
Large intestine polyp
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17.9%
10/56 • Number of events 10 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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21.2%
11/52 • Number of events 11 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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15.8%
9/57 • Number of events 9 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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11.7%
12/103 • Number of events 12 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
|
General disorders
Polyp
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8.9%
5/56 • Number of events 5 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
3.8%
2/52 • Number of events 2 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
10.5%
6/57 • Number of events 6 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
8.7%
9/103 • Number of events 9 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
|
Nervous system disorders
Headache
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19.6%
11/56 • Number of events 11 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
17.3%
9/52 • Number of events 10 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
17.5%
10/57 • Number of events 11 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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19.4%
20/103 • Number of events 20 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
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General disorders
Fatigue
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17.9%
10/56 • Number of events 10 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
9.6%
5/52 • Number of events 5 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
3.5%
2/57 • Number of events 2 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
|
9.7%
10/103 • Number of events 10 • Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonoscopy and 7 days post-colonoscopy.
Safety was assessed via performance of physical exams, vital signs, 12-lead ECG, laboratory safety tests (hematology, biochemistry and urinalysis) and the occurrence of adverse events.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee this was stipulated in the contract
- Publication restrictions are in place
Restriction type: OTHER