Trial Outcomes & Findings for Clinical Management of Neuropathic Pain With Ramelteon (NCT NCT00753623)
NCT ID: NCT00753623
Last Updated: 2017-05-15
Results Overview
Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.
TERMINATED
NA
23 participants
VAS score at baseline and after the treatment period
2017-05-15
Participant Flow
Subjects were recruited in person at the MGH Center for Pain or by advertisement throughout MGH and the local community.
Participant milestones
| Measure |
Placebo Phase I; Ramelteon Phase II
In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.
Ramelteon : ramelteon (8 mg)
|
Ramelton Phase I; Placebo Phase II
In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.
Ramelteon : ramelteon (8 mg)
|
|---|---|---|
|
Phase I (14 Days)
STARTED
|
11
|
12
|
|
Phase I (14 Days)
COMPLETED
|
9
|
8
|
|
Phase I (14 Days)
NOT COMPLETED
|
2
|
4
|
|
Washout (7 Days)
STARTED
|
9
|
8
|
|
Washout (7 Days)
COMPLETED
|
8
|
8
|
|
Washout (7 Days)
NOT COMPLETED
|
1
|
0
|
|
Phase II (14 Days)
STARTED
|
8
|
8
|
|
Phase II (14 Days)
COMPLETED
|
8
|
7
|
|
Phase II (14 Days)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Phase I; Ramelteon Phase II
In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.
Ramelteon : ramelteon (8 mg)
|
Ramelton Phase I; Placebo Phase II
In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.
Ramelteon : ramelteon (8 mg)
|
|---|---|---|
|
Phase I (14 Days)
Withdrawal by Subject
|
1
|
1
|
|
Phase I (14 Days)
Physician Decision
|
1
|
2
|
|
Phase I (14 Days)
Adverse Event
|
0
|
1
|
|
Washout (7 Days)
Physician Decision
|
1
|
0
|
|
Phase II (14 Days)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Clinical Management of Neuropathic Pain With Ramelteon
Baseline characteristics by cohort
| Measure |
Placebo Phase I; Ramelteon Phase II
n=11 Participants
In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.
Ramelteon : ramelteon (8 mg)
|
Ramelton Phase I; Placebo Phase II
n=12 Participants
In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.
Ramelteon : ramelteon (8 mg)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: VAS score at baseline and after the treatment periodPopulation: Only 15 subjects completed both treatment phases so we only included these subjects in the analysis.
Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.
Outcome measures
| Measure |
Ramelteon
n=15 Participants
Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
|
Placebo
n=15 Participants
Participants who received placebo medication during the first or last 2 weeks of the study.
|
|---|---|---|
|
Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments
|
-1.0 units on a scale
Standard Deviation 1.4
|
-1.1 units on a scale
Standard Deviation 1.5
|
Adverse Events
Ramelteon
Placebo
Serious adverse events
| Measure |
Ramelteon
n=23 participants at risk
Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
|
Placebo
n=23 participants at risk
Participants who received placebo medication during the first or last 2 weeks of the study.
|
|---|---|---|
|
Immune system disorders
Hospitalization
|
4.3%
1/23 • Number of events 1 • Two weeks for each intervention and a 1 week period of no intervention in between phases.
|
0.00%
0/23 • Two weeks for each intervention and a 1 week period of no intervention in between phases.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jianren Mao
MGH Center for Translational Pain Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place